NCT02474485

Absorb BVS vs. Drug Coated Balloon for Treatment Of ISR

Absorb Bioresorbable Scaffold vs. Drug Coated Balloon for Treatment Of In-Stent-Restenosis

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: SIS Medical AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

AbsorbISR is a randomized, controlled trial, single center, prospective, not blinded to evaluate two strategies of in stent restenosis treatment: Implantation of drug eluting bioresorbable stent scaffold Absorb® vs. balloon angioplasty with drug eluting balloon Sequent Please®.

Detailed description

This is randomized-controlled trial of Absorb® Bioresorbable Vascular Scaffold (BVS) vs. Sequent Please® drug coated balloon in an all-comers population with in-stent-restenosis (ISR). The patients will be randomized in a 1:1 fashion and the investigators intend to include 150 patients. All patients presenting with ISR and requiring percutaneous coronary intervention will be eligible to be included in this study. This will include patients with stable angina and those presenting with acute coronary syndrome (ACS). The primary objective of this study is to demonstrate superiority of the Absorb® bioresorbable scaffold compared to the Sequent Please® Drug Coated Balloon when treating patients with In-Stent-Restenosis regards to primary endpoint - angiographic late lumen loss at 9 month follow-up.

Conditions

• Coronary Artery Disease
• Coronary Restenosis

Interventions

Type	Name	Description
DEVICE	BVS Absorb implantation.	Absorb bioresorbable vascular scaffold will be implanted to treat in stent restenosis in target vessel.
DEVICE	DEB Sequent Please inflation.	Inflation of drug eluting balloon Sequent Please will be performed to treat in stent restenosis in target vessel.
PROCEDURE	Control coronary angiography.	Control coronary angiography will be performed at 9 month follow-up.
PROCEDURE	OCT visualization.	OCT visualization will be performed during index procedure and at 9 month follow-up.
OTHER	Clinical observation.	Patients will be informed that Investigator will contact them at 12, 24 and 60 months after the procedure. Investigator will collect information regarding clinical status of Patients, cardiac medications and any adverse events that occurred since the last follow-up.

Timeline

• Start date: 2015-03-01
• Primary completion: 2018-05-01
• Completion: 2021-06-01
• First posted: 2015-06-17
• Last updated: 2018-03-09

Locations

1 site across 1 country: Switzerland