Clinical trial NCT03529006: Absorb Bioresorbable Scaffold vs. Drug Coated Balloon for Treatment Of In-Stent-Restenosis
Official title: Absorb Bioresorbable Scaffold vs. Drug Coated Balloon for Treatment Of In-Stent-Restenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: In-stent Restenosis
Keywords: bioresorbable vascular scaffold
drug eluting balloon
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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).

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