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

Luzerner Kantonsspital0 sites53 target enrollmentMarch 2015

ConditionsIn-stent Restenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: In-stent Restenosis
Sponsor: Luzerner Kantonsspital
Enrollment: 53
Primary Endpoint: Angiographic late lumen loss at 9 months
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

March 2015

End Date

June 2020

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Luzerner Kantonsspital

Responsible Party

Principal Investigator

Wojciech Zasada

Clinical Trial Administrator

Luzerner Kantonsspital

Eligibility Criteria

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 BMS (bare metal stent), DES (drug eluting stent) or BVS, ISR in lesion previously treated by POBA (plain old balloon angioplasty), 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

•Difficulty with deliver and implant the Absorb scaffold (e.g. highly calcified lesions).
•Patients who have any contraindications for using DEB (SeQent Please) or BVS (Absorb).

Outcomes

Primary Outcomes

Angiographic late lumen loss at 9 months

Time Frame: 9 months

Late lumen loss will be calculated based on index and control coronary angiography.

Secondary Outcomes

- Incidence of in-stent-restenosis, target lesion failure, target vessel revascularisation, stent thrombosis in in-hospital and long-term observation(9 months)
- Early, late and very late probable or definite stent thrombosis(9 months)
- Cardiac and non-cardiac death in both groups(9 months)
- Result of index procedure assessment in OCT post procedure - struts apposition assessment.(During index procedure.)
- Result of index procedure assessment in OCT post procedure - dissections.(During index procedure.)
- 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))(9 months)
- OCT assessment of long-term study results - lumen area.(9 months)
- Result of index procedure assessment in OCT post procedure - stent area.(During index procedure.)
- Incidence of periprocedural complications: unplanned use of GP IIb/IIIa (Glycoprotein IIb/IIIa) inhibitors, vessel rupture, side branch occlusion, peri-procedural myocardial infarction(9 months)
- 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))(9 months)
- 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))(9 months)
- Assessment of possibility vessel measurement and stent diameter/length choice based on this measurement performed in OCT (Optical Coherence Tomography)(During index procedure.)
- Result of index procedure assessment in OCT post procedure - stent expansion index.(During index procedure.)
- OCT assessment of long-term study results - struts apposition assessment.(9 months)
- Lumen volume change between index and 9M (nine months) FU in OCT.(9 months)
- Result of index procedure assessment in OCT post procedure - lumen area.(During index procedure.)
- OCT assessment of long-term study results - stent area.(9 months)
- OCT assessment of long-term study results - lumen volume.(9 months)
- OCT assessment of long-term study results - neointimal volume.(9 months)
- Minimal lumen area change between index and 9M (nine months) FU in OCT.(9 months)