Safety and Clinical Performance of a Sirolimus-eluting Absorbable Metal Scaffold (BIOSOLVE-India)

Biotronik

Status: Suspended

Conditions: Coronary Artery Disease

Treatments: Device: Bioresorbable scaffold

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02916485

C1601

Details and patient eligibility

About

Assessment of the clinical performance and the safety of the Magmaris Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold in a cohort of patients in India with de novo coronary artery lesions.

Full description

This is a prospective, multi-centre, single-arm, open label trial to assess the safety and clinical performance of Magmaris Drug Eluting Absorbable Metal Scaffold.

A total of up to 110 patients with de novo lesions in native coronary arteries will be enrolled at up to 8 investigational sites in India.

In-hospital clinical follow-up visits will take place at 1 and 6 months post procedure.

The primary endpoint is target lesion failure (a composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction, coronary artery bypass grafting, clinically driven target lesion revascularization) at 1 month post procedure.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is ≥ 18 years and ≤ 80 years of age
2. Written subject informed consent available prior to percutaneous coronary intervention (PCI). Remark: Vulnerable subjects may not be enrolled in this trial
3. Subject with stable or unstable angina pectoris or documented silent ischemia
4. Subject eligible for PCI
5. Subject acceptable candidate for coronary artery bypass surgery
6. Subject with a maximum of two single de novo lesions in two different major epicardial vessels
7. Reference vessel diameter between 2.7-3.7 mm by visual estimation, depending on the scaffold size used
8. Target lesion length ≤ 21 mm by visual estimation, depending on the scaffold size used
9. Target lesion stenosis by visual estimation ≥ 50% - < 100% and TIMI flow ≥1
10. Eligible for Dual Anti Platelet Therapy (DAPT)

Exclusion criteria

1. Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
2. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure. Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment
3. Subjects with a ≥2 fold CK level or in absence of CK a ≥3 fold CKMB level above the upper range limit within 24 hours prior to the index procedure
4. Left main coronary artery disease
5. Three-vessel coronary artery disease at time of procedure
6. Thrombus in target vessel
7. Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
8. Planned interventional treatment of any non-target vessel within 30 days post-procedure
9. Subject is on dialysis
10. Planned intervention of the target vessel after the index procedure
11. Ostial target lesion (within 3.0 mm of vessel origin)
12. Target lesion involves a side branch >2.0 mm in diameter
13. Documented left ventricular ejection fraction (LVEF) ≤ 30%
14. Heavily calcified lesion
15. Target lesion is located in or supplied by an arterial or venous bypass graft
16. The target lesion requires treatment with a device other than the pre-dilatation balloon prior to the Magmaris study device placement (including but not limited to directional coronary atherectomy, excimer laser, rotational atherectomy, etc.)
17. Unsuccessful pre-dilatation, defined as minimal lumen diameter smaller than the respective crossing profile of the Magmaris study device and angiographic complications (e.g. distal embolization, side branch closure, extensive dissections that can't be covered by a single scaffold), by visual estimation
18. Known allergies to: Acetylsalicylic Acid (ASA), Heparin, contrast medium, Sirolimus, Everolimus or similar drugs (i.e., ABT 578, Biolimus, Tacrolimus), PLLA, Silicon Carbide, Magnesium, Yttrium, Neodymium, Zirconium, Gadolinium, Dysprosium, Tantalum
19. Impaired renal function (serum creatinine > 2.5 mg/dl or 221 µmol/l) determined within 72 hours prior to index procedure
20. Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are not excluded) or has known life limiting immunosuppressive or autoimmune disease (e.g.,human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
21. Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off detected during diagnostic angiography
22. Life expectancy less than 6 months
23. Planned surgery or dental surgical procedure within 6 months after index procedure
24. Subject with tortuous vessel that may impair scaffold placement in the region of obstruction or proximal to the lesion
25. In the investigators opinion subjects will not be able to comply with the follow-up requirements.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Bioresorbable scaffold

Experimental group

Description:

Percutaneous coronary intervention (PCI) with a sirolimus-eluting resorbable coronary magnesium scaffold

Treatment:

Device: Bioresorbable scaffold