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

NCT02916485 | Suspended

• 1 other identifier: C1601
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

bioresorbable scaffold; vascular restoration therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Target lesion failure (TLF)

  6 months post-procedure

• Target vessel failure (TVF)

  1 and 6 months post-procedure

• Clinically driven target lesion revascularization

  1 and 6 months post-procedure

• Cardiac death

  1 and 6 months post-procedure

• Myocardial infarction

  1 and 6 months post-procedure

Study Arms (1)

Bioresorbable scaffold

EXPERIMENTAL

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

Device: Bioresorbable scaffold

Interventions

Bioresorbable scaffold DEVICE

Percutaneous coronary intervention (PCI)

Also known as: Sirolimus-eluting resorbable coronary magnesium scaffold, Magmaris

Bioresorbable scaffold

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
• 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
• 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
• Left main coronary artery disease
• Three-vessel coronary artery disease at time of procedure
• Thrombus in target vessel
• Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
• Planned interventional treatment of any non-target vessel within 30 days post-procedure
• Subject is on dialysis
• Planned intervention of the target vessel after the index procedure
• Ostial target lesion (within 3.0 mm of vessel origin)
• Target lesion involves a side branch \>2.0 mm in diameter
• Documented left ventricular ejection fraction (LVEF) ≤ 30%
• Heavily calcified lesion
• Target lesion is located in or supplied by an arterial or venous bypass graft

Sponsors & Collaborators

• Biotronik AG: lead
• CBCC-VIBGYOR Research Pvt. Ltd.: collaborator

Study Sites (1)

All India Institute of Medical Sciences

Delhi, 110029, India

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: September 27, 2016
• Study Start: June 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: September 1, 2018
• Last Updated: June 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)