Safety and Clinical Performance of a Sirolimus-eluting Absorbable Metal Scaffold

NCT ID: NCT02916485

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-30
• Study Completion Date: 2018-09-30

Brief Summary

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.

Detailed 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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bioresorbable scaffold

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

Group Type: EXPERIMENTAL

Bioresorbable scaffold

Intervention Type: DEVICE

Percutaneous coronary intervention (PCI)

Interventions

Bioresorbable scaffold

Percutaneous coronary intervention (PCI)

Intervention Type: DEVICE

Other Intervention Names

Sirolimus-eluting resorbable coronary magnesium scaffold; Magmaris

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CBCC-VIBGYOR Research Pvt. Ltd.

OTHER

Sponsor Role: collaborator

Biotronik AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

All India Institute of Medical Sciences

Delhi, , India

Countries

India

Other Identifiers

C1601

Identifier Type: -

Identifier Source: org_study_id