RECRUITING

MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions

Conditions

In-Stent Restenosis Cardiovascular Diseases Coronary Artery Disease Drug coated balloon Sirolimus coated balloon ISR Magic Touch SCB Concept Medical MAGICAL ISR

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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

A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus- Coated Balloon in the Treatment of Coronary Drug-Eluting Stent In-Stent Restenosis. Subjects with prior DES implantation presenting with ISR lesions undergoing PCI will be randomized into two groups: treatment with the MagicTouch™ sirolimus-coated balloon or POBA on a 2:1 basis. Approximately 492 subjects will be enrolled in the randomized study in a maximum of 50 study sites located in the United States. The goal is to establish the safety and efficacy of the MagicTouch™ sirolimus- coated balloon in treatment of coronary in-stent restenosis (ISR).

Official Title

MagicTouch Sirolimus-coated Balloon for Treatment of In-Stent Restenosis in Coronary Artery Lesions

Quick Facts

Study Start:2024-04-16

Study Completion:2028-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05908331

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 to 110 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject is at least 18 years old 2. Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment 3. Patient with an indication for PCI due to suspected in-stent restenosis 4. Non-target lesion PCI are allowed in non-target vessels to be treated with approved interventional devices prior to randomization as follows:	1. STEMI within 72 hours of presentation to the first treating hospital, whether a transfer facility or the study hospital 2. NSTEACS in whom the biomarkers have not peaked 3. PCI within the 24 hours prior to the index procedure (not including PCI performed in non-target lesions during the index procedure) 4. Cardiogenic shock (defined as persistent hypotension \[systolic blood pressure \<90 mm Hg\] or requiring vasoactive or hemodynamic support, including IABP) 5. Subject is intubated 6. Known left ventricular ejection fraction \<30% 7. Relative or absolute contraindication to DAPT for at least 1 month (e.g., planned surgeries that cannot be delayed) 8. Subject has an indication for chronic oral anticoagulation treatment and a contraindication for concomitant treatment with a P2Y12 inhibitor 9. If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath 10. Hemoglobin \<9 g/dL 11. Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3 12. White blood cell count \<3,000 cells/mm3 13. Active infection undergoing treatment 14. Clinically significant liver disease 15. Renal insufficiency as defined by estimated glomerular filtration rate (eGFR) to be \<30ml/min by the MDRD formula 16. Active peptic ulcer or active bleeding from any site 17. Bleeding from any site requiring active medical attention within the prior 8 weeks 18. History of bleeding diathesis or coagulopathy or likely to refuse blood transfusions 19. Cerebrovascular accident (CVA) within 3 months or has any permanent neurological defect as a result of CVA 20. Known allergy to the study device components or protocol-required concomitant medications: 21. Any co-morbid condition that may cause non-compliance with the protocol (e.g. dementia, substance abuse, etc.) or reduce life expectancy to \<24 months (e.g. cancer, heart failure, lung disease, severe valvular disease) 22. Patient is participating in or plans to participate in any other investigational drug or device trial that has not reached its primary endpoint 23. Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test within one week before index procedure) 24. Women who intend to become pregnant within 12 months after the index procedure 25. Patient has received an organ transplant or is on a waiting list for an organ transplant 26. Patient has received chemotherapy within 30 days before the index procedure or scheduled to receive chemotherapy any time after the index procedure 27. Patient is receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease. Inhaled steroid and steroid use for contrast- allergy prophylaxis or treatment are allowed 1. More than 1 ISR lesion in the target vessel in segments that cannot be treated by a single 40 mm length DCB (see Angiographic Inclusions #5 and #6 above) 2. Unprotected left main lesions \>50% or left main intervention 3. Primary PCI for STEMI 4. Coronary artery disease judged more suitable for surgical revascularization per guidelines and local heart team discussion 5. Another lesion in either the target vessel or non-target vessel is present that requires or has a high probability of requiring PCI within 12 months after the index procedure 6. Prior brachytherapy or DCB treatment of target lesion 7. Target lesion is a bifurcation restenosis involving both branches of a bifurcation in which the side branch reference vessel diameter is \>2.0 mm 8. Target lesions located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft 9. Target lesion contains large thrombus 10. Target lesion is heavily calcified 11. Target lesion is a chronic total occlusion 12. Diffuse distal disease to target lesion with impaired runoff

Inclusion Criteria

Exclusion Criteria

1. Subject is at least 18 years old
2. Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment
3. Patient with an indication for PCI due to suspected in-stent restenosis
4. Non-target lesion PCI are allowed in non-target vessels to be treated with approved interventional devices prior to randomization as follows:

1. STEMI within 72 hours of presentation to the first treating hospital, whether a transfer facility or the study hospital
2. NSTEACS in whom the biomarkers have not peaked
3. PCI within the 24 hours prior to the index procedure (not including PCI performed in non-target lesions during the index procedure)
4. Cardiogenic shock (defined as persistent hypotension \[systolic blood pressure \<90 mm Hg\] or requiring vasoactive or hemodynamic support, including IABP)
5. Subject is intubated
6. Known left ventricular ejection fraction \<30%
7. Relative or absolute contraindication to DAPT for at least 1 month (e.g., planned surgeries that cannot be delayed)
8. Subject has an indication for chronic oral anticoagulation treatment and a contraindication for concomitant treatment with a P2Y12 inhibitor
9. If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath
10. Hemoglobin \<9 g/dL
11. Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3
12. White blood cell count \<3,000 cells/mm3
13. Active infection undergoing treatment
14. Clinically significant liver disease
15. Renal insufficiency as defined by estimated glomerular filtration rate (eGFR) to be \<30ml/min by the MDRD formula
16. Active peptic ulcer or active bleeding from any site
17. Bleeding from any site requiring active medical attention within the prior 8 weeks
18. History of bleeding diathesis or coagulopathy or likely to refuse blood transfusions
19. Cerebrovascular accident (CVA) within 3 months or has any permanent neurological defect as a result of CVA
20. Known allergy to the study device components or protocol-required concomitant medications:
21. Any co-morbid condition that may cause non-compliance with the protocol (e.g. dementia, substance abuse, etc.) or reduce life expectancy to \<24 months (e.g. cancer, heart failure, lung disease, severe valvular disease)
22. Patient is participating in or plans to participate in any other investigational drug or device trial that has not reached its primary endpoint
23. Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test within one week before index procedure)
24. Women who intend to become pregnant within 12 months after the index procedure
25. Patient has received an organ transplant or is on a waiting list for an organ transplant
26. Patient has received chemotherapy within 30 days before the index procedure or scheduled to receive chemotherapy any time after the index procedure
27. Patient is receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease. Inhaled steroid and steroid use for contrast- allergy prophylaxis or treatment are allowed
1. More than 1 ISR lesion in the target vessel in segments that cannot be treated by a single 40 mm length DCB (see Angiographic Inclusions #5 and #6 above)
2. Unprotected left main lesions \>50% or left main intervention
3. Primary PCI for STEMI
4. Coronary artery disease judged more suitable for surgical revascularization per guidelines and local heart team discussion
5. Another lesion in either the target vessel or non-target vessel is present that requires or has a high probability of requiring PCI within 12 months after the index procedure
6. Prior brachytherapy or DCB treatment of target lesion
7. Target lesion is a bifurcation restenosis involving both branches of a bifurcation in which the side branch reference vessel diameter is \>2.0 mm
8. Target lesions located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
9. Target lesion contains large thrombus
10. Target lesion is heavily calcified
11. Target lesion is a chronic total occlusion
12. Diffuse distal disease to target lesion with impaired runoff

Contacts and Locations

Study Contact

Dario Gattuso

CONTACT

+393292467132

dario@conceptmedical.com

Farhana Siddique

CONTACT

+919725495366

farhana@conceptmedical.com

Study Locations (Sites)

Cheek-Powell Heart and Vascular Pavilion

Clearwater, Florida, 33756

United States

Cardiology Associates Research, LLC

Tupelo, Mississippi, 38801

United States

Atlanticare Regional Medical Center

Pomona, New Jersey, 08240

United States

Montefiore Medical Center - Moses Division

Bronx, New York, 10467

United States

NYU Langone Health

New York, New York, 10016

United States

Columbia University Medical Center/NYPH

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: Concept Medical Inc.

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 Date2024-04-16

Study Completion Date2028-02

Study Record Updates

Study Start Date2024-04-16

Study Completion Date2028-02

Terms related to this study

Keywords Provided by Researchers

Drug coated balloon
Sirolimus coated balloon
ISR
Magic Touch
SCB
Concept Medical
MAGICAL ISR

Additional Relevant MeSH Terms

In-Stent Restenosis
Cardiovascular Diseases
Coronary Artery Disease