NCT01710748

Reservoir-Based Polymer-Free Amphilimus-Eluting Stent Versus Polymer-Based Everolimus-Eluting Stent in Diabetic Patients

Reservoir-Based Polymer-Free Amphilimus-Eluting Stent Versus Polymer-Based Everolimus-Eluting Stent in Diabetic Patients (RESERVOIR) Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Spanish Society of Cardiology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, randomized controlled, single blind, two-arm, multicenter clinical evaluation. Diabetic patients (n=112) with de novo coronary artery disease will be randomized to one of the 2 treatment arms: 1) Reservoir-Based Polymer-Free Amphilimus-Eluting Stent or 2) Polymer-Based Everolimus-Eluting Stent. The purpose of this study is to determine whether Polymer-Free Amphilimus-Eluting Stent implantation is effective in reducing neointimal hyperplasia as compared to Polymer-Based Everolimus-Eluting Stent in diabetic patients, using Optical Coherence Tomography (OCT) as the primary imaging modality.

Detailed description

In patients with diabetes mellitus (DM), drug eluting stents (DES) have been shown to be associated with greater neointimal suppression than bare-metal stents. However, there is an ongoing debate on the optimal drug-eluting stent in diabetic patients. This study is a prospective, randomized controlled, single blind, two-arm, multicenter clinical evaluation. Diabetic patients (n=112) with de novo coronary artery disease will be randomized to one of the 2 treatment arms: 1) Reservoir-Based Polymer-Free Amphilimus-Eluting Stent or 2) Polymer-Based Everolimus-Eluting Stent. The purpose of this study is to determine whether Polymer-Free Amphilimus-Eluting Stent implantation is effective in reducing neointimal hyperplasia as compared to Polymer-Based Everolimus-Eluting Stent in diabetic patients, using Optical Coherence Tomography (OCT) as the primary imaging modality.

Conditions

• Coronary Artery Disease
• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Polymer-Based Everolimus-Eluting Stent	Polymer-Based Everolimus-Eluting Stent
DEVICE	Polymer-Free Amphilimus-Eluting Stent	Reservoir-Based Polymer-Free Amphilimus-Eluting Stent

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-07-01
• Completion: 2014-10-01
• First posted: 2012-10-19
• Last updated: 2013-11-06

Locations

4 sites across 1 country: Spain