NCT02916485

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

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Biotronik AG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Bioresorbable scaffold	Percutaneous coronary intervention (PCI)

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-02-01
• Completion: 2018-09-01
• First posted: 2016-09-27
• Last updated: 2017-06-14

Locations

1 site across 1 country: India