RECRUITING

SELUTION4BTK Trial

Conditions

Peripheral Arterial Disease Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in CLTI patients.

Official Title

SELUTION SLR™ 014 BTK: A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 Drug Eluting Balloon in the Treatment of Below-the-Knee (BTK) Atherosclerotic Disease in Patients With Chronic Limb Threatening Ischemia (CLTI)

Quick Facts

Study Start:2022-05-19

Study Completion:2028-07-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05055297

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject age is ≥ 18 years or older depending on local regulations. 2. Subject life expectancy is ≥ 1 year. 3. Subject has documented chronic limb-threatening ischemia in the target limb with Rutherford classification category 4 or 5 and symptoms of \> 2 weeks duration. 4. Subject is willing and able to provide written informed consent and comply with study procedures and required follow-up evaluations. 5. Female subjects of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure.	1. Subject has extensive tissue loss (Rutherford category 6) extending above the trans metatarsal level, salvageable only with complex foot reconstruction or non-traditional trans metatarsal amputations. This includes subjects with: 1. Osteomyelitis involving proximal to the metatarsal head(s) 2. Any heel wound or wound with calcaneal bone involvement 2. Subject has chronic renal insufficiency (dialysis dependent, or glomerular filtration rate \[GFR\] ≤ 30 ml/min/1.73 m2 within 30 days of index procedure) or has undergone renal transplantation. 3. Subject has acute renal insufficiency confirmed by 50% increase of serum creatinine within 48 hours before procedure and/or decrease in urine output. 4. Subject has acute limb ischemia with onset of index limb symptoms less than 2 weeks prior to index procedure. 5. Subjects has wounds that are deemed to be neuropathic or non-ischemic in nature or any venous or mixed wounds. 6. Subject has had prior major amputation of the ipsilateral extremity or planned major amputation of either leg. 7. Target limb iliac or common femoral artery bypass within 6 weeks of index procedure. 8. Prior (within 14 days) or planned (within 30 days) surgical or endovascular procedures. The following procedures are permitted: 1. Target limb inflow treatment at the index procedure, provided it meets the criteria in Angiographic Inclusion Criteria #12 2. Contralateral limb iliac artery treatment 3. Diagnostic angiography 4. Foot wound debridement 5. Planned minor amputation of digit(s) at the phalangeal level 9. Target lesion has undergone prior DCB within 1 year, or ANY prior DES or bare metal stent (BMS) treatment (no in-stent restenosis \[ISR\] treatment is permitted). Note: Prior stent is permitted if the target lesion is located ≥ 30 mm from the stent AND there is ≤ 30% in-stent diameter stenosis. 10. Target lesion(s) requires treatment with alternative therapies such as thrombolysis, thrombus aspiration, stenting, cryoplasty, brachytherapy, or re-entry device. Note: The following adjunctive lesion preparation therapies are permitted: Atherectomy (rotational, orbital, directional or laser), cutting/scoring/contoured balloon, or intravascular lithotripsy. 11. Target lesion requires treatment via pedal access or upper extremity access. 12. Subject has undergone non-coronary artery treatment with any limus-based drug coated balloon (DCB) or DES or other device within 3 months prior to index procedure. 13. Subject has known hypersensitivity or allergy to Sirolimus or other pharmacologic agents required for the procedure (such as contrast agent, heparin, bivalirudin) that cannot be adequately pre-treated. 14. Subject has contraindication to antiplatelet therapy. 15. Subject has experienced disabling stroke or ST-segment elevation myocardial infarction (STEMI) within 3 months of index procedure. 16. Subject has acute coronary syndrome. Stabilized Acute Coronary Syndrome (ACS) is permitted. 17. Subject has non-atherosclerotic disease of the target vessel (including aneurysmal disease and vasculitis) or Buerger's disease. 18. Subject has hypercoagulable state or disorder, or coagulopathy, including platelet count ≤ 100,000 per microliter. 19. Subject has systemic infection (White Blood Count \[WBC\] \> 12,000 and febrile). \[Note: Enrollment permitted after successful treatment of infection with resolution of leukocytosis and/or febrile state\]. 20. Subject is known to be immune compromised (e.g., Human Immunodeficiency virus \[HIV\], Systemic Lupus Erythematosus \[SLE\]) or is receiving treatment with immune suppressive medications (NOTE: topical corticosteroids are permitted) 21. Subject is receiving (or is scheduled to receive) cancer treatment with surgery or chemotherapy or radiation therapy or has metastatic malignancy. Note: local application of chemotherapeutic creams is allowed. 22. Subject has New York Heart Association (NYHA) class IV congestive heart failure. 23. Subject is bedridden. 24. Subject has a body mass index (BMI) \< 18. 25. Subject is currently participating in another investigational drug or device study that has not completed primary endpoint follow-up. 26. Subject has other anatomic, medical, social, or psychological conditions that in the investigator's opinion could limit the patient's ability to participate in the clinical study and/or comply with the follow-up requirements.

Inclusion Criteria

Exclusion Criteria

1. Subject age is ≥ 18 years or older depending on local regulations.
2. Subject life expectancy is ≥ 1 year.
3. Subject has documented chronic limb-threatening ischemia in the target limb with Rutherford classification category 4 or 5 and symptoms of \> 2 weeks duration.
4. Subject is willing and able to provide written informed consent and comply with study procedures and required follow-up evaluations.
5. Female subjects of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure.

1. Subject has extensive tissue loss (Rutherford category 6) extending above the trans metatarsal level, salvageable only with complex foot reconstruction or non-traditional trans metatarsal amputations. This includes subjects with:
1. Osteomyelitis involving proximal to the metatarsal head(s)
2. Any heel wound or wound with calcaneal bone involvement
2. Subject has chronic renal insufficiency (dialysis dependent, or glomerular filtration rate \[GFR\] ≤ 30 ml/min/1.73 m2 within 30 days of index procedure) or has undergone renal transplantation.
3. Subject has acute renal insufficiency confirmed by 50% increase of serum creatinine within 48 hours before procedure and/or decrease in urine output.
4. Subject has acute limb ischemia with onset of index limb symptoms less than 2 weeks prior to index procedure.
5. Subjects has wounds that are deemed to be neuropathic or non-ischemic in nature or any venous or mixed wounds.
6. Subject has had prior major amputation of the ipsilateral extremity or planned major amputation of either leg.
7. Target limb iliac or common femoral artery bypass within 6 weeks of index procedure.
8. Prior (within 14 days) or planned (within 30 days) surgical or endovascular procedures. The following procedures are permitted:
1. Target limb inflow treatment at the index procedure, provided it meets the criteria in Angiographic Inclusion Criteria #12
2. Contralateral limb iliac artery treatment
3. Diagnostic angiography
4. Foot wound debridement
5. Planned minor amputation of digit(s) at the phalangeal level
9. Target lesion has undergone prior DCB within 1 year, or ANY prior DES or bare metal stent (BMS) treatment (no in-stent restenosis \[ISR\] treatment is permitted). Note: Prior stent is permitted if the target lesion is located ≥ 30 mm from the stent AND there is ≤ 30% in-stent diameter stenosis.
10. Target lesion(s) requires treatment with alternative therapies such as thrombolysis, thrombus aspiration, stenting, cryoplasty, brachytherapy, or re-entry device. Note: The following adjunctive lesion preparation therapies are permitted: Atherectomy (rotational, orbital, directional or laser), cutting/scoring/contoured balloon, or intravascular lithotripsy.
11. Target lesion requires treatment via pedal access or upper extremity access.
12. Subject has undergone non-coronary artery treatment with any limus-based drug coated balloon (DCB) or DES or other device within 3 months prior to index procedure.
13. Subject has known hypersensitivity or allergy to Sirolimus or other pharmacologic agents required for the procedure (such as contrast agent, heparin, bivalirudin) that cannot be adequately pre-treated.
14. Subject has contraindication to antiplatelet therapy.
15. Subject has experienced disabling stroke or ST-segment elevation myocardial infarction (STEMI) within 3 months of index procedure.
16. Subject has acute coronary syndrome. Stabilized Acute Coronary Syndrome (ACS) is permitted.
17. Subject has non-atherosclerotic disease of the target vessel (including aneurysmal disease and vasculitis) or Buerger's disease.
18. Subject has hypercoagulable state or disorder, or coagulopathy, including platelet count ≤ 100,000 per microliter.
19. Subject has systemic infection (White Blood Count \[WBC\] \> 12,000 and febrile). \[Note: Enrollment permitted after successful treatment of infection with resolution of leukocytosis and/or febrile state\].
20. Subject is known to be immune compromised (e.g., Human Immunodeficiency virus \[HIV\], Systemic Lupus Erythematosus \[SLE\]) or is receiving treatment with immune suppressive medications (NOTE: topical corticosteroids are permitted)
21. Subject is receiving (or is scheduled to receive) cancer treatment with surgery or chemotherapy or radiation therapy or has metastatic malignancy. Note: local application of chemotherapeutic creams is allowed.
22. Subject has New York Heart Association (NYHA) class IV congestive heart failure.
23. Subject is bedridden.
24. Subject has a body mass index (BMI) \< 18.
25. Subject is currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.
26. Subject has other anatomic, medical, social, or psychological conditions that in the investigator's opinion could limit the patient's ability to participate in the clinical study and/or comply with the follow-up requirements.

Contacts and Locations

Study Contact

Kara Piscani

CONTACT

+14846805857

kara.piscani@cordis.com

Tamarah Suys

CONTACT

+41788957756

tamarah.suys@cordis.com

Study Locations (Sites)

St. Bernards Medical Center

Jonesboro, Arkansas, 72401

United States

Arkansas Heart Hospital

Little Rock, Arkansas, 72211

United States

St. Helena Hospital

Saint Helena, California, 94574

United States

ClinRé

Thornton, Colorado, 80023

United States

Vascular Care Group

Darien, Connecticut, 06820

United States

Yale University

New Haven, Connecticut, 06519

United States

The Cardiac and Vascular Institute Research Foundation

Gainesville, Florida, 32605

United States

Palm Vascular Centers

Miami, Florida, 33141

United States

Cardiovascular Consultants of South Georgia

Thomasville, Georgia, 31792

United States

Advocate Aurora Research Institute

Oak Lawn, Illinois, 60453

United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068

United States

Vascular Institute of the Midwest

Davenport, Iowa, 52807

United States

Cardiovascular Institute of the South

Gray, Louisiana, 70359

United States

MedStar Health Research Institute

Hyattsville, Maryland, 20782

United States

Beth Israel Medical Center

Boston, Massachusetts, 02215

United States

University of Massachusetts Medical Center

Worcester, Massachusetts, 01655

United States

NC Heart and Vascular Research, LLC

Raleigh, North Carolina, 27607

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Miriam Hospital

Providence, Rhode Island, 02906

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Tennessee Center for Clinical Trials

Tullahoma, Tennessee, 37388

United States

Baylor College of Medicine

Houston, Texas, 77030

United States

Texas Cardiac and Vascular Institute San Antonio

San Antonio, Texas, 78229

United States

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507

United States

Collaborators and Investigators

Sponsor: MedAlliance, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-19

Study Completion Date2028-07-30

Study Record Updates

Study Start Date2022-05-19

Study Completion Date2028-07-30

Terms related to this study

Additional Relevant MeSH Terms

Peripheral Arterial Disease
Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities