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

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease; In-Stent Restenosis; Cardiovascular Diseases
• Interventions: Device: Plan balloon Angioplasty (POBA); Device: Sirolimus Drug Coated Balloon

• Registration Number: NCT05908331
• Lead Sponsor: Concept Medical Inc.

Brief Summary

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).

Detailed Description

All subjects providing informed consent will have their medical history reviewed and will undergo a physical examination, laboratory screen, and a standardized 12-lead ECG within 7 days of procedure. Women of childbearing potential will have a pregnancy test within one week prior to the procedure. If subjects meet the inclusion and exclusion criteria of the study, they will be randomized to one of two treatment groups, and will then undergo treatment with MagicTouch™ sirolimus-coated balloon or POBA of the target ISR lesion, per trial protocol.

One pre-procedure and all post-procedure biomarker blood draws will be sent to a central core laboratory for analysis of troponin T. Evaluation of post-procedural biomarker blood draws in local laboratories are not mandated but may be performed as part of standard of care.

During the index hospitalization, patients will undergo a clinical assessment and 12-lead ECG; and they will have cardiac biomarkers drawn before the intervention to establish baseline biomarker level and confirmation that the biomarkers are falling. At least one post procedure biomarker (core lab) will be drawn at a minimum of 4 hours after PCI as part of the assessment of periprocedural myocardial infarction and significant periprocedural myocardial injury (at 6-8 hour intervals depending on whether the patient remains admitted). If no procedural complications have occurred and there are no signs of ischemia on post-procedure ECG or clinical assessment, the patient may be discharged per local practice and no additional biomarker levels need to be drawn (beyond the protocol-mandated core laboratory draw at a minimum of 4 hours). If the patient remains admitted cardiac biomarkers (core lab) should be drawn every 6-8 hours until at least 2 total post-procedural core laboratory biomarker draws have passed or clinical standard-based biomarker levels have peaked per local labs or the patient is discharged.

After hospital discharge, subjects will be followed at 30 days (+1 week), 6 months (+2 weeks), and 12 months (+1 month) and then 24, 36, 48 and 60 months (+1 month) post procedure. Yearly vital status information will be collected by telephone follow-up. At the 12-month visit, subjects will undergo 12-lead ECG, blood count, coagulation profile and blood chemistry tests. New and ongoing AEs and concomitant medications will also be assessed.

All elective angiograms performed on the target vessel during the 12-month follow-up period should be preceded by a physician evaluation, during which the physician will indicate whether the subject's clinical status warrants revascularization, i.e. the subject has clinical evidence of ischemia. All films, including unscheduled angiograms, are to be sent to the angiographic core laboratory for review. The angiographic core laboratory will be blinded.

Study Timeline

• Study First Submitted: 2023-06-01
• Study First Submitted QC: 2023-06-09
• Study First Posted: 2023-06-18
• Study Start: 2024-04-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Primary Completion: 2025-09
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 492

Inclusion 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:

Angiographic Inclusion Criteria:

1. In-stent restenosis after drug-eluting stent implantation(s) in the target lesion (i.e. single and multiple stent layer ISR cases are eligible)
2. Target lesion must have visually estimated stenosis ≥50% and less than 100% diameter stenosis in symptomatic patients; or a visually estimated target lesion diameter stenosis of ≥70%, or by evidence of ischemia by coronary physiology (fractional flow reserve [FFR] ≤0.80 or non-hyperemic pressure ratio [NHPR] ≤0.89) in absence of symptoms
3. Successful lesion preparation (residual stenosis <30%), without complications (no or slow flow, flow-limiting dissection, perforation, distal embolization) and without plan for stenting
4. Target lesion in a native coronary artery
5. Thrombolysis In Myocardial Infartction (TIMI) grade flow ≥1 in target lesion
6. Target reference vessel diameter (visual estimation) >2.0 and ≤4.0 mm
7. Target lesion length (including tandem lesions) ≤36.0 mm (visual estimation) and can be covered by only one balloon
8. One ISR target lesion (overlapping stents are allowed) to be treated per patient and in single major coronary artery or side branch (reference vessel diameter >2.0 mm)
9. Other coronary lesions (ISR or non-ISR) in non-target vessel are allowed and may be treated by any approved interventional device, but must be treated successfully prior to randomization

Exclusion Criteria

General Exclusion Criteria (all must be absent for the patient to be eligible):

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. Prior DCB treatment (coronary or off-label peripheral) of target lesion ISR

5. Cardiogenic shock (defined as persistent hypotension [systolic blood pressure <90 mm Hg] or requiring vasoactive or hemodynamic support, including IABP)

6. Subject is intubated

7. Known left ventricular ejection fraction <30%

8. Relative or absolute contraindication to DAPT for at least 1 month (e.g., planned surgeries that cannot be delayed)

9. Subject has an indication for chronic oral anticoagulation treatment and a contraindication for concomitant treatment with a P2Y12 inhibitor

10. If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath

11. Hemoglobin <9 g/dL

12. Platelet count <100,000 cells/mm3 or >700,000 cells/mm3

13. White blood cell count <3,000 cells/mm3

14. Active infection undergoing treatment

15. Clinically significant liver disease

16. Renal insufficiency as defined by estimated glomerular filtration rate (eGFR) to be <30ml/min by the MDRD formula

17. Active peptic ulcer or active bleeding from any site

18. Bleeding from any site requiring active medical attention within the prior 8 weeks

19. History of bleeding diathesis or coagulopathy or likely to refuse blood transfusions

20. Cerebrovascular accident (CVA) within 3 months or has any permanent neurological defect as a result of CVA

21. Known allergy to the study device components or protocol-required concomitant medications:

    • sirolimus (as well as other limus drugs, analogues, or similar compounds), aspirin, clopidogrel and prasugrel and ticagrelor, heparin and bivalirudin, or iodinated contrast that cannot be adequately pre-medicated

22. 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)

23. Patient is participating in or plans to participate in any other investigational drug or device trial that has not reached its primary endpoint

24. Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test within one week before index procedure)

25. Women who intend to become pregnant within 12 months after the index procedure

26. Patient has received an organ transplant or is on a waiting list for an organ transplant

27. Patient has received chemotherapy within 30 days before the index procedure or scheduled to receive chemotherapy any time after the index procedure

28. 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

Angiographic Exclusion Criteria (visual estimate) (all must be absent for the patient to be eligible):

1. More than 1 ISR lesion in the target vessel in segments that cannot be treated by a single 40mm length DCB (see Angiographic Inclusions #5 and #6 above)
2. ISR lesion in the target vessel in a segment that corresponds to a previously established/documented bare metal stent (BMS)
3. Unprotected left main lesions >50% or left main intervention
4. Primary PCI for STEMI
5. Coronary artery disease judged more suitable for surgical revascularization per guidelines and local heart team discussion
6. 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
7. Prior brachytherapy or DCB treatment of target lesion
8. Target lesion is a bifurcation restenosis involving both branches of a bifurcation in which the side branch reference vessel diameter is >2.0 mm
9. Target lesions located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
10. Target lesion contains large thrombus
11. Target lesion is heavily calcified
12. Target lesion is a chronic total occlusion (or subtotal) without adequate lesion preparation.* Total and subtotal occlusions may be enrolled assuming they can be crossed with a wire and demonstrate TIMI grade 3 flow at the time of randomization.
13. Diffuse distal disease to target lesion with impaired runoff

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
POBA	Plan balloon Angioplasty (POBA)	plain old balloon angioplasty
MagicTouch Sirolimus-Coated Balloon	Sirolimus Drug Coated Balloon	Magic TouchTM is a Sirolimus Coated Balloon catheter intended to be used in coronary applications, treats the atherosclerosis of the coronary arteries by eluting the immunosuppressant agent Sirolimus without leaving behind a metallic scaffold.

Primary Outcome Measures

Name	Time	Method
TLF (Target Lesion Failure)	12 months	The composite rate of cardiac death, target-vessel MI (Myocardial Infarction) or ischemia-driven TLR (Target Lesion Revascularization)

Secondary Outcome Measures

Name	Time	Method
ID-TLR (Ischemia-Driven Target Lesion Revascularization)	30 days and 6, 12, 24, 36, 48, and 60 months	Repeat revascularization of the target lesion due to recurrent ischemia
MACE (Major adverse cardiovascular events)	30 days and 6, 12, 24, 36, 48, and 60 months	composite of cardiovascular mortality, any MI (Myocardial Infarction), and ID-TLR (Ischemia-Driven Target Lesion Revascularization)
BARC (Bleeding Academic Research Consortium) type 3-5 bleeding	30 days and 6, 12, 24, 36, 48, and 60 months	Significant or severe bleeding according to the BARC definition
ID-TVR (Ischemia-Driven Target Vessel Revascularization)	30 days and 6, 12, 24, 36, 48, and 60 months	Repeat revascularization of the target vessel due to recurrent ischemia
TVR (Target Vessel Revascularization)	30 days and 6, 12, 24, 36, 48, and 60 months	Repeat revascularization of the target vessel
Q-wave MI (Myocardial Infarction)	30 days and 6, 12, 24, 36, 48, and 60 months	Myocardial Infarction demonstrated by new pathological Q waves on ECG
TVF (Target vessel failure)	30 days and 6, 12, 24, 36, 48, and 60 months	composite of cardiovascular mortality, ID-TVR (Ischemia-Driven Target Vessel Revascularization), and TV-MI (Target Vessel Myocardial Infarction)
All-cause mortality	30 days and 6, 12, 24, 36, 48, and 60 months	Death from any cause
Cardiovascular mortality	30 days and 6, 12, 24, 36, 48, and 60 months	Death due to coronary artery disease or complications of coronary treatment
Any MI (Myocardial Infarction)	30 days and 6, 12, 24, 36, 48, and 60 months	Any Myocardial Infarction
TV-MI (Target Vessel Myocardial Infarction)	30 days and 6, 12, 24, 36, 48, and 60 months	Myocardial Infarction related to the target vessel
Probable target lesion stent thrombosis by ARC (Academic Research Consortium) criteria	30 days and 6, 12, 24, 36, 48, and 60 months	Probable stent thrombosis in the target lesion according to the ARC definition
Any revascularization	30 days and 6, 12, 24, 36, 48, and 60 months	any repeat PCI or CABG
Cardiovascular mortality or MI (Myocardial Infarction)	30 days and 6, 12, 24, 36, 48, and 60 months	Either cardiovascular death or any Myocardial Infarction
TLR (Target Lesion Revascularization)	30 days and 6, 12, 24, 36, 48, and 60 months	Repeat revascularization of the target lesion
Non-Q-wave MI (Myocardial Infarction)	30 days and 6, 12, 24, 36, 48, and 60 months	Myocardial Infarction not demonstrated by new pathological Q waves on ECG
All-cause mortality or MI (Myocardial Infarction)	30 days and 6, 12, 24, 36, 48, and 60 months	Either death from any cause or any Myocardial Infarction
Definite target lesion stent thrombosis by ARC (Academic Research Consortium) criteria	30 days and 6, 12, 24, 36, 48, and 60 months	Definite stent thrombosis in the target lesion according to the ARC definition
Procedure Success	30 days and 6, 12, 24, 36, 48, and 60 months	ability to deliver the device and achieve a less than 30% residual stenosis by QCA (quantitative coronary angiography) without major complication or bailout stenting
Any definite or probable target lesion stent thrombosis by ARC (Academic Research Consortium) criteria	30 days and 6, 12, 24, 36, 48, and 60 months	Definite or probable stent thrombosis in the target lesion according to the ARC (Academic Research Consortium) definition
All-cause mortality, MI (Myocardial Infarction), or TVR (Target Vessel Revascularization)	30 days and 6, 12, 24, 36, 48, and 60 months	Death from any cause, any Myocardial Infarction, or Target Vessel Revascularization

Trial Locations

Locations (27)

Cardiology, PC - Princeton Baptist Medical Center; 🇺🇸 Birmingham, Alabama, United States

Dignity Health - Mercy Gilbert Medical Center; 🇺🇸 Gilbert, Arizona, United States

Cedars - Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Yale University / Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States

Cheek-Powell Heart and Vascular Pavilion; 🇺🇸 Clearwater, Florida, United States

Clearwater Cardiovascular and Interventional Consultants; 🇺🇸 Clearwater, Florida, United States

The Cardiac & Vascular Institute Research Foundation; 🇺🇸 Gainesville, Florida, United States

Tampa General Hospital / University of South Florida; 🇺🇸 Tampa, Florida, United States

Atlanta VA Medical Center; 🇺🇸 Decatur, Georgia, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Metropolitan Heart and Vascular Institute; 🇺🇸 Coon Rapids, Minnesota, United States

Minneapolis Heart Institute Foundation; 🇺🇸 Minneapolis, Minnesota, United States

Cardiology Associates Research, LLC; 🇺🇸 Tupelo, Mississippi, United States

AtlantiCare Regional Medical Center; 🇺🇸 Pomona, New Jersey, United States

Montefiore Medical Center - Moses Division; 🇺🇸 Bronx, New York, United States

NYU Langone Health; 🇺🇸 New York City, New York, United States

VA New York Harbor Healthcare System; 🇺🇸 New York, New York, United States

Columbia University Medical Center/NYPH; 🇺🇸 New York, New York, United States

NC Heart and Vascular Research, LLC; 🇺🇸 Raleigh, North Carolina, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Oklahoma University Health (OU Health); 🇺🇸 Oklahoma City, Oklahoma, United States

Providence St. Vincent Medical Center; 🇺🇸 Portland, Oregon, United States

Prisma Health; 🇺🇸 Greenville, South Carolina, United States

Centennial Medical Center; 🇺🇸 Nashville, Tennessee, United States

Baylor Scott and White Heart and Vascular Hospital; 🇺🇸 Dallas, Texas, United States

Baylor Scott & White - The Heart Hospital - Plano; 🇺🇸 Plano, Texas, United States

West Virginia University and Vascular Institute; 🇺🇸 Morgantown, West Virginia, United States