209 Clinical Trials for Various Conditions
CERES-TANDEM is a multicenter study designed to improve the understanding of "tandem" ischemic stroke -those caused by two blockages in series, one in a neck artery and one in a brain artery-. Because tandem occlusion-related stroke tend to cause more severe brain injury and have been under-represented in major clinical trials, there is no clear consensus on which treatments work best. This study will help identify who is most at risk and which therapies lead to the best recovery. OBJECTIVES: Identify Risk Factors: Compare common stroke risk factors (e.g., high blood pressure, diabetes, high cholesterol, smoking) in patients with tandem occlusion versus those with single-site large vessel occlusions. Compare Clinical Outcomes of Reperfusion: Evaluate whether acute reperfusion treatments-such as clot-dissolving drugs (thrombolysis), mechanical clot removal (thrombectomy), and emergent carotid stenting-lead to better 3-month functional outcome (assessed by the modified Rankin Scale, ranging 0 to 6, with good functional outcome identified with mRS score 0-2) compared to medical management alone in tandem occlusion and isolated cervical artery occlusion. Assess Post Stent Therapy: Among patients who receive emergent stenting, determine whether different post-stenting regimens (antiplatelet agents, anticoagulants, or no additional therapy) affect functional outcomes, bleeding events, or stroke recurrence. STUDY DESIGN: Type: cohort study pooling data from prospective registries of cerebrovascular diseases at participating sites Setting: Stroke Unit, Cesena Hospital (PI MR), Interventional Neuroradiology, Vall d'Hebron Research Institute, Barcelona (PI FD), Radiology, Boston Medical Center (PI TN); and other participating stroke centers Time Frame: Patients treated between 2018 and 2024. Sample Size: Approximately 2800 cases overall DATA COLLECTION: Sources: Clinical records, imaging reports (CT perfusion, angiograms), lab results, hospital discharge summaries, and longitudinale stroke registry databases. Data Safety: case information is anonymized using encrypted study IDs; only aggregate data will be reported. Follow-Up: Standard-of-care follow-up visits at 3 months (minimum) and up to 12 months or until death. Outcomes include functional status (mRS), recurrence of stroke or TIA, symptomatic intracranial hemorrhage, major bleeding, and all-cause mortality OUTCOMES AND ANALYSIS: Primary Outcome: Functional outcome, identified by the mRS and tested between groups with ordinal shift between mRS categories (0-6). Secondary Outcomes: functional status at 3 months (excellent outcome mRS 0-1, good outcome mRS 0-2) Additional outcomes: early neurological deterioration; symptomatic intracerebral hemorrhage and successful recanalization (defined as TICI 2b or higher). PLANNED ANALYSIS (see Detailed Description for full analytical protocol): * Compare outcomes in emergent stenting vs no stenting groups depending on stent subtype and endovascular approach * Compare outcomes in emergent stenting vs no stenting groups depending on antithrombotic treatment before, during and after the endovascular procedure * Define the potential impact of early statin treatment on the interplay between stenting vs no stenting and the outcomes. STATISTICS: Medians with IQRs and means with SDs together with percentages will be used to present the distribution of ordinal, continuous, and categorical variables. Baseline characteristics across groups will be compared using the Pearson χ2 test for categorical variables and t test or the Kruskal-Wallis test, as appropriate, for continuous and ordinal variables. Given the nature of data deriving from prospective registries, inverse probability of treatment weighting (IPTW) will be implemented, which is an application of propensity scores that calculates the probability of being exposed to one treatment versus the other and creates a pseudo-population based on the probabilities so that potential confounders are equally distributed across the treatment groups. Models will be weighted for prespecified variables known to potentially impact the outcome, and will also consider factors of imbalance between groups. In case of crossovers, a stratum-based analysis according to predefined estimand will be applied (direct intervention effect on outcomes and total-effect; estimand approach in detailed description). DISSEMINATION The results will be disseminated in international peer reviewed journals. CERES-TANDEM is promoted by * Bufalini Stroke Center, AUSL Romagna, Cesena, Italy (PI Dr. M. Romoli) * Interventional Neuroradiology Unit, Vall d'Hebron Institut de Recerca, Barcelona, Spain (PI Dr. F. Diana) * Boston Medical Center and Boston University School of Medicine, Boston, Massachusetts, USA (PI Dr. T. Nguyen)
Central retinal artery occlusion (CRAO) is an ophthalmologic emergency which leads to severe and permanent vision loss. There is no evidence-based therapy for CRAO. The objective of this GION study is to evaluate the efficacy and safety of KUS121 intravitreal (IVT) injection in participants with acute non-arteritic CRAO.
Transradial access (TRA) is the preferred vascular access site for invasive coronary angiography. TRA is limited by blockage of the radial artery post-procedurally, preventing future use of TRA. This is referred to as radial artery occlusion (RAO) and occurs in \~5% of cases. While intraprocedural anticoagulation has been studied extensively to mitigate this complication, oral anticoagulation post-TRA has not. The investigators will assess the impact of a one-week course of rivaroxaban post-TRA to reduce the rate of ultrasound-defined RAO at 30 days.
For this retrospective study, the investigators will collect and analyze data of patients who presented with posterior artery occlusion and underwent mechanical thrombectomy (the type of endovascular stroke treatment) and intravenous thrombolysis (the type of non-endovascular stroke treatment). The electronic health records will be queried for the demographic, medical history, and outcomes data of all patients with posterior cerebral artery occlusion who underwent mechanical thrombectomy, intravenous thrombolysis (IVT), or medical management.
Coronary angiography is performed to evaluate for obstructive coronary artery disease. This is commonly performed via the transfemoral or transradial approach with the latter increasing in frequency. One of the most common complications of transradial access is radial artery occlusion occurring in \~5% of patients which prohibits the use of the radial artery in the future. There is evidence to support the use of intraprocedural anticoagulation to mitigate the risk of radial artery occlusion however the role of post-procedural anticoagulation has not been previously evaluated. Rivaroxaban is a direct oral anticoagulant (DOAC) with a safety profile superior to that of vitamin K antagonists. Given the safety profile, ease of use, and feasibility of DOAC therapy, our study will endeavor to evaluate the use of rivaroxaban 15mg orally once daily for 7 days after transradial access and the impact this has on the rate of radial artery occlusion.
Background: TAVR is a common therapy for people with heart problems. It stands for transcatheter aortic valve replacement, TAVR can be a better option than surgery. But it isn t safe for everyone. It may block the arteries that supply blood to the heart muscle by pushing heart valve tissue outward. Researchers want to study a method that may make TAVR safer. It is known as Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA). Objective: To study the feasibility and safety of BASILICA in people at high risk of coronary artery obstruction that complicates TAVR. Eligibility: People at least 21 years old whose heart doctors do not think they can have TAVR safely Design: Participants will be screened by a team of heart specialists. They will have heart and blood tests. They will answer questions. Participants will have TAVR using BASILICA. They will get general anesthesia or they will be sedated. While using x-rays and echocardiography, doctors will cross and split the aortic valve leaflet using an electrified wire. A standard TAVR valve will be implanted. After the procedure, participants will have blood tests and physical exams. They will answer questions. They will have heart tests. Participants will have a scan within 1 month and after 12 months. They will have heart tests during follow-up visits in the first year. Sponsoring Institute: National Heart, Lung and Blood Institute
Collect confirmatory evidence of the safety and effectiveness of the Balloon LIFESTREAM™ Stent Graft for the treatment of stenoses and occlusion in the iliac arteries.
The purpose of this study is to establish the rate of radial artery occlusion post transradial cardiac catheterization through different modalities. The study hypothesis is that specialized imaging can provide specific information to help identify hand complications after cardiac catheterization through the wrist.
The objective of this prospective, non-randomized, multicenter, post-market, observational study is to compile clinical data on percutaneous techniques used to obtain tibiopedal access and to cross infrainguinal arterial occlusions.
The Provisional Heparin TherApy on Radial Artery Occlusion after transradial coronary angiography and patent Hemostasis (PHARAOH) study compares the strategy of standard a-priori heparin use in patients undergoing transradial coronary angiography to a strategy of provisional heparin administration only if patent hemostasis is not achievable.
The primary purpose of this Phase 2 study is to optimize Plasmin delivery by comparing different delivery regimens in patients with peripheral arterial occlusion. The study includes a blinded plasminogen activator treatment group and a blinded plasminogen activator placebo group. The study will also assess safety and tolerability of Plasmin at 150 and 250 mg doses.
The primary objective is to evaluate safety and tolerability of single and repeated administrations of escalating doses of NV1FGF administered intramuscularly in patients with severe Peripheral Artery Occlusive Disease (PAOD), (Rutherford's Grade II, category 4 or Grade III, category 5 and 6). Secondary objectives are: * To determine the biological activity of NV1FGF on collateral artery development. * To evaluate the activity of NV1FGF on hemodynamic and clinical parameters.
The primary objective is to evaluate the transgene expression (synthesis of FGF-1 mRNA) in injected tissue, at injection site, after Intra Muscular (IM) administration of increasing single doses of NV1FGF. Secondary objectives : * To evaluate the safety and tolerability of IM administration of increasing single doses of NV1FGF * To evaluate the transgene expression (FGF-1 protein) in injected tissues (injection site and remote site) * To evaluate the presence of FGF-1 receptors in injected tissues (injection site and remote site) * To evaluate the NV1FGF biodistribution in injected tissues (injection site and remote site), in multiple organs/tissues when appropriate, and plasma * To evaluate the transgene expression (synthesis of FGF-1 mRNA) in injected tissue at remote site * To collect data from plasma NV1FGF pharmacokinetics * To evaluate healing of the amputation site
A retrospective review with four year followup on patients that had previously been enrolled in a study to evaluate blockages in the lower legs. The study looked at patients that had undergone a bypass of the leg from the groin to the knee area with an incision in each area using general anesthesia. These patients were compared to others who had undergone treatment with balloon dilatation and stents in the arteries in the thighs with only numbing medicine. The study was completed two years ago and was initially designed to look at outcomes at 24 months. Now the investigators are trying to go back and look at outcomes of these patients' treatment at 4 years by simply reviewing their records.
Peripheral Arterial Occlusive Disease (PAOD) is a condition caused by ischemia in the legs due to atherosclerotic disease affecting the larger arteries of the legs. Chronic PAOD can be regarded as a marker of generalized atherosclerosis. PAOD threatens the survival of an extremity and often causes lifelong disablement from a painful leg. The clinical consequences of PAOD include pain on walking (claudication), pain at rest and loss of tissue integrity in the distal limbs.A variety of medical therapies have been investigated for patients with PAOD. There is currently no evidence to suggest that any medical therapy is effective for patients with rest pain and/or ischemic ulcers. Also, the use of intramuscular angiogenic VEGF-A gene transfer has recently demonstrated a improvement in clinical and hemodynamic status in patients with severe PAOD
This study is a comparison of two different ways to treat blockage in the artery of the thigh. The first is an older way with incisions in the groin and just above the knee. A plastic tube is then inserted to make a bypass from the groin to the knee. The second treatment offered is through a needle hole in the groin. A thin plastic tube covering a metal stent is inserted into the artery and released to bypass the blockage from inside the artery. No incisions are needed. Patients are enrolled and then selected for one treatment method or another by chance. The patients will be followed for two years to see how the two different treatment methods work compared to each other.
This study will determine the risk of brain aneurysm (abnormal outpouching of a brain artery) in young adults who had their carotid artery tied off as an infant as part of the extracorporeal membrane oxygenation (ECMO) procedure. This procedure is sometimes performed on newborns with lung problems so that they can have oxygen brought to their blood outside the body. ECMO operates similar to a heart-lung machine. Blood drained from the veins has the carbon dioxide removed and oxygen added. The oxygenated blood is then returned to the body through the arteries. People 18 to 25 years of age who underwent ECMO as an infant at the Children's National Medical Center in Washington, D.C., may be eligible for this study. Participants undergo the following procedures: * Medical history and physical and neurological examinations. * Magnetic resonance imaging (MRI) of the head and neck. MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The subject lies in the scanner (a metal cylinder surrounded by a magnetic field) for about 90 minutes, lying still for up to 15 minutes at a time. During part of the procedure, a contrast dye is injected into a vein through a catheter (thin plastic tube) to enhance the images.
The objective of this study is to evaluate the safety and effectiveness of Doppler guided uterine artery occlusion (D-UAO) for the reduction of fibroid associated bleeding.
This phase I clinical trial will evaluate the safety and efficacy of intra-coronary injection of AC133 selected autologous marrow-derived stem cells in patients with chronic coronary artery occlusion. A clinical study to determine the therapeutic potential of marrow-derived stem cells as an adjunct therapy to current standard therapies for CAD is warranted. The current initiative is to investigate a model of chronic myocardial ischemia and (1) to determine whether intra-coronary injection of selected autologous marrow-derived AC133 stem cells is reasonably safe for use in humans and (2) if this treatment shows any improvement in coronary perfusion, as assessed using non-invasive imaging. This study is structured to evaluate the feasibility and safety of autologous AC133+ bone marrow-derived stem cell via intra-coronary injection into documented ischemic but viable myocardial zones via established collateral vessels. The epicardial vessel that normally supplies the ischemic zone must be 100% chronically occluded and considered non-revascularizable by percutaneous means.
This trial is for patients with acute occlusion of one of the arteries supplying blood to the leg. The trial is designed to determine the safety and activity of a novel clot dissolving (thrombolytic) drug (alfimeprase).
This is the first clinical research trial in which intravenous Prostaglandin E1 (PGE1 is a vasoactive hormone) will be used as supportive treatment along with the angioplasty procedure to treat or open up a blocked artery within one lower limb or the most affected of two limbs in subjects with Peripheral Arterial Occlusive Disease.
The purpose of this clinical study is to compare how well two different devices achieve hemostasis in patients undergoing a transfemoral transcatheter aortic valve replacement. Both devices are approved by the FDA for this use, and have already been used by clinicians on patients undergoing transfemoral procedures. It is believed that the use of both devices in combination compared to the Perclose alone will shorten the time that it takes to 'seal' the artery, resulting in a shorter period of time that manual pressure will be held, shorter procedure time and less complications after the procedure.
The purpose of this clinical study is to compare how well two different devices for achieving hemostasis perform in patients undergoing transfemoral procedures with 6 French Access. Both devices are approved by the FDA for this use, and have already been used by clinicians on patients undergoing transfemoral procedures. It is believed that the use of both devices in combination compared to the Perclose alone will shorten the time that it takes to 'seal' the artery, resulting in a shorter period of time that patients would need to lay flat.
The study is designed to evaluate the safety and efficacy of the AngioSafe Peripheral CTO Crossing System.
The purpose of this clinical study is to compare how well two different devices for achieving hemostasis perform in patients undergoing transradial procedures. Both devices are approved by the FDA for this use, and have already been used by clinicians on patients undergoing transradial procedures. It is believed that the use of both devices in combination compared to the hemostasis band (TR band) alone will shorten the time that it takes to 'seal' the artery, resulting in a shorter period of time that you would need to wear the hemostasis band.
The primary objectives of this study are to evaluate the performance of StatSeal Advanced used in conjunction with the TR Band (SSA) as compared to the TR Band without SSA (TRB) relative to: the incidence of peri-procedural radial artery occlusion (RAO) at discharge or 24 hours, whichever occurs first, and the Time to Hemostasis (TTH).
Radial artery access is increasingly becoming popular among interventional cardiologists for patients undergoing percutaneous coronary intervention(PCI)/ diagnostic angiography secondary to its low complications rates. However, it is frequently associated with the spasm of the radial artery which can lead to difficulty in catheter manipulation during the procedure and potentially leading to vessel trauma. This vessel trauma can cause activation of coagulation system and formation of clot and subsequently the occlusion of radial artery. In this study the investigators intend to find the association of radial artery spasm with the future development of radial artery occlusion in patients who undergo PCI via radial access.
The object of the study is to determine whether different doses of PZ-128, when added to standard medical care in persons undergoing cardiac catheterization/percutaneous coronary intervention, will increase the risk of bleeding. A secondary objective is to determine whether patients treated with PZ-128 have fewer cardiac events such as heart attack, bypass surgery or stroke compared with those persons treated with the standard of care.
This study compares cognitive function after carotid endarterectomy and stenting.
Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) in the legs and decreased blood flow to the legs. This may cause difficulty or pain with walking or other activities that use leg muscles. Exercise may help improve blood flow in the legs and improve the ability to walk. This research project is being implemented in adults with PAD to examine the effects of exercise or weight loss programs on lower extremity blood flow, health, and physical function.