Absorb BVS vs. Drug Coated Balloon for Treatment Of ISR

Not Applicable

Suspended

• Conditions: Coronary Artery Disease; Coronary Restenosis
• Interventions: Device: BVS Absorb implantation.; Device: DEB Sequent Please inflation.; Procedure: Control coronary angiography.; Procedure: OCT visualization.; Other: Clinical observation.

• Registration Number: NCT02474485
• Lead Sponsor: SIS Medical AG

Brief 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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-06-11
• Study First Submitted QC: 2015-06-12
• Study First Posted: 2015-06-17
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-08
• Last Update Posted: 2018-03-09
• Primary Completion: 2018-05
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 years or above.
• Diagnosed with ISR requiring percutaneous coronary intervention: visual diameter stenosis > 70 % and/or Fractional Flow Reserve < 0.81 and/or non-invasive testing demonstrating ischemia. This real-life population with in-stent restenosis beside typical stable patients with ISR includes ACS patients with thrombus containing lesions, patients with multivessel disease, patients with ISR in non-infarct related artery, with ISR in bare metal stent (BMS), drug eluting stent (DES) or bioresorbable vascular scaffold (BVS), ISR in lesion previously treated by plain old balloon angioplasty (POBA), drug eluting balloon (DEB) or additional stent implantation.
• Double anti-platelet therapy for the duration of at least 12 months is considered possible at the time of intervention

Exclusion Criteria

• The participant may not enter the study if the interventionist has doubts that he is not able to deliver and implant the Absorb scaffold (e.g. highly calcified lesions).
• Patients who have any contraindications for using DEB (SeQent Please) or BVS (Absorb) specified in instructions for use are not able to participate in this study.
• Women with childbearing potential must have a negative result of pregnancy test and they must use an effective contraception method for at least 12 months after study procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEB - Sequent Please	OCT visualization.	In DEB - Sequent Please Group, dilatation of drug eluting balloon Sequent Please ® will be used for treatment of the narrowed part of the artery. In this arm following interventions will be performed: * DEB Sequent Please inflation. For in stent restenosis treatment during index procedure. * OCT visualization.During index procedure and at 9 month follow-up. * Control coronary angiography. Control angiography will be performed at 9 month follow-up. * Clinical observation. Clinical observation will be performed at 9, 12 and 60 month follow-up.
BVS - Absorb	BVS Absorb implantation.	BVS - Absorb scaffold group will be treated by implantation of drug eluting bioresorbable vascular scaffold (Absorb®). In this arm following interventions will be performed: * BVS Absorb implantation. For in stent restenosis treatment during index procedure. * OCT visualization.During index procedure and at 9 month follow-up. * Control coronary angiography. Control angiography will be performed at 9 month follow-up. * Clinical observation. Clinical observation will be performed at 9, 12 and 60 month follow-up.
BVS - Absorb	OCT visualization.	BVS - Absorb scaffold group will be treated by implantation of drug eluting bioresorbable vascular scaffold (Absorb®). In this arm following interventions will be performed: * BVS Absorb implantation. For in stent restenosis treatment during index procedure. * OCT visualization.During index procedure and at 9 month follow-up. * Control coronary angiography. Control angiography will be performed at 9 month follow-up. * Clinical observation. Clinical observation will be performed at 9, 12 and 60 month follow-up.
DEB - Sequent Please	DEB Sequent Please inflation.	In DEB - Sequent Please Group, dilatation of drug eluting balloon Sequent Please ® will be used for treatment of the narrowed part of the artery. In this arm following interventions will be performed: * DEB Sequent Please inflation. For in stent restenosis treatment during index procedure. * OCT visualization.During index procedure and at 9 month follow-up. * Control coronary angiography. Control angiography will be performed at 9 month follow-up. * Clinical observation. Clinical observation will be performed at 9, 12 and 60 month follow-up.
DEB - Sequent Please	Control coronary angiography.	In DEB - Sequent Please Group, dilatation of drug eluting balloon Sequent Please ® will be used for treatment of the narrowed part of the artery. In this arm following interventions will be performed: * DEB Sequent Please inflation. For in stent restenosis treatment during index procedure. * OCT visualization.During index procedure and at 9 month follow-up. * Control coronary angiography. Control angiography will be performed at 9 month follow-up. * Clinical observation. Clinical observation will be performed at 9, 12 and 60 month follow-up.
DEB - Sequent Please	Clinical observation.	In DEB - Sequent Please Group, dilatation of drug eluting balloon Sequent Please ® will be used for treatment of the narrowed part of the artery. In this arm following interventions will be performed: * DEB Sequent Please inflation. For in stent restenosis treatment during index procedure. * OCT visualization.During index procedure and at 9 month follow-up. * Control coronary angiography. Control angiography will be performed at 9 month follow-up. * Clinical observation. Clinical observation will be performed at 9, 12 and 60 month follow-up.
BVS - Absorb	Control coronary angiography.	BVS - Absorb scaffold group will be treated by implantation of drug eluting bioresorbable vascular scaffold (Absorb®). In this arm following interventions will be performed: * BVS Absorb implantation. For in stent restenosis treatment during index procedure. * OCT visualization.During index procedure and at 9 month follow-up. * Control coronary angiography. Control angiography will be performed at 9 month follow-up. * Clinical observation. Clinical observation will be performed at 9, 12 and 60 month follow-up.
BVS - Absorb	Clinical observation.	BVS - Absorb scaffold group will be treated by implantation of drug eluting bioresorbable vascular scaffold (Absorb®). In this arm following interventions will be performed: * BVS Absorb implantation. For in stent restenosis treatment during index procedure. * OCT visualization.During index procedure and at 9 month follow-up. * Control coronary angiography. Control angiography will be performed at 9 month follow-up. * Clinical observation. Clinical observation will be performed at 9, 12 and 60 month follow-up.

Primary Outcome Measures

Name	Time	Method
Angiographic late lumen loss at 9 month follow-up.	At 9 month follow up.	Angiographic late lumen loss will be compared between both study groups.

Secondary Outcome Measures

Name	Time	Method
Comparison of rate of restenosis between both groups and in specific populations (patients with acute coronary syndromes, patients with diabetes, patients with long lesions (> 25 mm)).	Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Cardiac and non-cardiac death in both groups.	During 60 month follow-up.
Incidence of periprocedural complications: side branch occlusion.	Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Incidence of target lesion failure in long-term observation.	During 60 month follow-up.
Incidence of target vessel revascularisation in long-term observation.	During 60 month follow-up.
Occurence of stent thrombosis (defined as early, late and very late probable or definite according to ARC definition).	During 60 month follow-up.
Result of index procedure assessment in OCT post procedure (lumen/stent area, struts assessment, dissections, stent expansion).	Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Incidence of periprocedural complications: unplanned use of GP IIb/IIIa inhibitors.	Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Incidence of periprocedural complications: vessel rupture.	Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Incidence of periprocedural complications: peri-procedural myocardial infarction.	Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Comparison of diameter stenosis between both groups and in specific populations (patients with acute coronary syndromes, patients with diabetes, patients with long lesions (> 25 mm)).	Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Incidence of in-stent-restenosis in long-term observation.	During 60 month follow-up.
Incidence of stent thrombosis in long-term observation.	During 60 month follow-up.
Comparison of minimal luminal diameter between both groups and in specific populations (patients with acute coronary syndromes, patients with diabetes, patients with long lesions (> 25 mm)).	Participants will be followed for the duration of index procedure, an expected average of 1 hour.
OCT assessment of long-term study results (lumen/stent area, struts assessment, neointimal volume, lumen volume).	At 9 month follow-up.
Assessment of possibility vessel measurement and stent diameter/length choice based on these measurement in optical coherence tomography (OCT).	Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Lumen volume change between index and 9 month follow-up OCT.	OCT parameters change will be assessed between index hospitalization and 9 month follow-up.
Minimal lumen area change between index and 9 month follow-up OCT.	OCT parameters change will be assessed between index hospitalization and 9 month follow-up.

Trial Locations

Locations (1)

Luzernen Kantonsspital, Spitalstrasse 16; 🇨🇭 Luzern, Switzerland