NCT03529006

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Luzerner Kantonsspital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to demonstrate superiority of the Absorb scaffold compared to the Sequent Please Drug Coated Balloon when treating patients with In-Stent-Restenosis (ISR).

Detailed description

Absorb ISR is randomized-controlled trial of Absorb scaffold vs. Sequent Please drug coated balloon in an all-comers population with in-stent-restenosis. The patients will be randomized in a 1:1 fashion and the investigators intend to include 150 patients. Repeat coronary angiography will be performed 9 months post intervention in all subjects. Optical coherence tomography will be performed at baseline and at 9 months in both groups. 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).

Conditions

• In-stent Restenosis

Interventions

Type	Name	Description
PROCEDURE	Sequent Please inflation	PCI procedure for treatment of ISR with DEB - Sequent Please - inflation
PROCEDURE	Absorb BVS implantation	PCI procedure for treatment of ISR with Absorb BVS implantation

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-09-01
• Completion: 2020-06-01
• First posted: 2018-05-18
• Last updated: 2018-05-18