Safety and Efficacy Study of the Amaranth Medical APTITUDE Bioresorbable Drug-Eluting Coronary Stent — RENASCENT II  

Coronary Artery Disease Clinical Trial

Official title: Restoring Endoluminal Narrowing Using Bioresorbable Scaffolds - Extended Trial II

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the safety and performance of a new version of a coronary artery stent for treating blockages in the arteries supplying blood to the heart muscle. The Amaranth Medical APTITUDE scaffold releases a drug (sirolimus) to reduce the likelihood of the treated blood vessel developing a new blockage. In addition, the scaffold dissolves away over time, leaving no permanent implant after the blood vessel has healed.

Clinical Trial Description

The objective of this study is to evaluate the safety and performance of the AmM APTITUDE Bioresorbable Drug-Eluting Coronary Scaffold for use in the treatment of single, de novo, stenotic native coronary artery lesions in patients undergoing elective percutaneous coronary intervention. The scaffold is a single-use device comprised of a balloon-expandable, intracoronary drug coated scaffold pre-mounted on a rapid-exchange delivery catheter. The scaffold is made of Poly-L-Lactide (PLLA) and is coated with a polymer-antiproliferative drug (sirolimus) matrix. The scaffold provides mechanical support similar to a metallic stent to the vessel while it is healing, and then gradually breaks down over time leaving no permanent implant in the treated vessel. Compared to prior versions of the scaffold, the new device has a thinner strut design (a wall thickness of 120 µm rather than 150 µm), but is otherwise identical.

The study design is a prospective, non-randomized, multi-center, non-inferiority trial. It will enroll a maximum of 60 patients from up to 12 investigational centers in Colombia and the European Union. Eligible patients who are at least 18 years of age diagnosed with symptomatic ischemic disease due to a discrete, single, de novo, stenotic lesion in native coronary artery will be asked to participate in this study. After treatment with the investigational device, subjects will be followed for five years. Safety of the device will be evaluated using the incidence of target vessel failure during the follow-up period. Performance (efficacy) will be assessed using the in-scaffold late lumen loss measured by quantitative coronary angiography at nine months. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

• NCT number: NCT02568462
• Study type: Interventional
• Source: Amaranth Medical Inc.
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 2015
• Completion date: July 2021