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

Coronary Artery Disease Clinical Trial

— BIOSOLVE-India  

Official title:

BIOTRONIK - Safety and Clinical Performance Of the Magmaris Drug Eluting Absorbable Metal Scaffold in a Cohort of Patients in India With de Novo Lesions in NatiVE Coronary Arteries

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02916485
• Other study ID #: C1601
• Status: Suspended
• Phase: N/A
• First received: September 23, 2016
• Last updated: June 13, 2017
• Start date: June 2017
• Est. completion date: September 2018

Study information

• Verified date: June 2017
• Source: Biotronik AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: September 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Bioresorbable scaffold
Percutaneous coronary intervention (PCI)

Locations

Country	Name	City	State
India	All India Institute of Medical Sciences	Delhi

Sponsors (2)

Lead Sponsor	Collaborator
Biotronik AG	CBCC-VIBGYOR Research Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion failure	TLF is a composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI), coronary artery bypass graft (CABG), clinically driven target lesion revascularization (TLR)	1 month post-procedure
Secondary	Target lesion failure (TLF)	TLF is a composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI), coronary artery bypass graft (CABG), clinically driven target lesion revascularization (TLR)	6 months post-procedure
Secondary	Target vessel failure (TVF)	TVF is a composite of cardiac death, target vessel Q-wave or non-Q wave myocardial infarction (MI), coronary artery bypass graft (CABG), clinically driven target vessel revascularization (TVR)	1 and 6 months post-procedure
Secondary	Clinically driven target lesion revascularization		1 and 6 months post-procedure
Secondary	Cardiac death		1 and 6 months post-procedure
Secondary	Myocardial infarction		1 and 6 months post-procedure
Secondary	Scaffold thrombosis	Scaffold thrombosis is composite of definite and probable scaffold thrombosis according to ARC definition	1 and 6 months post-procedure
Secondary	Incidence of procedure success	Procedure Success is a composite of achievement of a final diameter stenosis of <30% by visual assessment or on-line quantitative coronary angiography, without the occurrence of death, Q-wave or non-Q-wave MI, or repeat revascularization of the target lesion during the hospital stay (3 days plus or minus 2 days)	3 days (plus or minus 2 days)
Secondary	Incidence of device success	Device Success is a composite of a final residual diameter stenosis of <30% by visual assessment or on-line quantitative coronary angiography, using the assigned device only, successful delivery of the scaffold to the target lesion site in the coronary artery, appropriate scaffold deployment, successful removal of the device, safe removal of the device in case of deployment failure.	Participants will be followed for the duration of index procedure, an expected average of 1 hour.