NCT02255864

Safety and Efficacy Study of the Amaranth Medical FORTITUDE Bioresorbable Drug-Eluting Coronary Stent

Restoring Endoluminal Narrowing Using Bioresorbable Scaffolds - European Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Amaranth Medical Inc. · Industry
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and performance of a new coronary artery stent for treating blockages in the arteries supplying blood to the heart muscle. The Amaranth FORTITUDE 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.

Detailed description

The objective of this study is to evaluate the safety and performance of the AmM FORTITUDE 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. The study design is a prospective, non-randomized, multi-center, non-inferiority trial. It will enroll a maximum of 120 patients from up to 10 investigational centers in 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.

Conditions

• Coronary Artery Disease
• Myocardial Ischemia

Interventions

Type	Name	Description
DEVICE	AmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold	Placement of the investigational device into the diseased coronary artery to eliminate the vascular stenosis.

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-07-01
• Completion: 2020-11-01
• First posted: 2014-10-03
• Last updated: 2016-06-08

Locations

5 sites across 1 country: Italy