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

Luzerner Kantonsspital53 enrolled

Overview

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).

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

In-stent Restenosis

Interventions

Sequent Please inflationPROCEDURE

PCI procedure for treatment of ISR with DEB - Sequent Please - inflation

Absorb BVS implantationPROCEDURE

PCI procedure for treatment of ISR with Absorb BVS implantation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Time frame: 9 months

Secondary Outcomes

- Incidence of periprocedural complications: unplanned use of GP IIb/IIIa (Glycoprotein IIb/IIIa) inhibitors, vessel rupture, side branch occlusion, peri-procedural myocardial infarction

Periprocedural complications will be analyzed as combined endpoint and separately for all defined complication.

Time frame: 9 months

- 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))

The angiographic parameter will be compared separately in all defined subgroups.

Time frame: 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))

The angiographic parameter will be compared separately in all defined subgroups.

Time frame: 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))

The angiographic parameter will be compared separately in all defined subgroups.

Time frame: 9 months

- Incidence of in-stent-restenosis, target lesion failure, target vessel revascularisation, stent thrombosis in in-hospital and long-term observation

Four clinical complications will be compared separately between study groups.

Data from ClinicalTrials.gov

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Time frame: 9 months

- Early, late and very late probable or definite stent thrombosis

Detailed description of all events of stent thrombosis will be presented.

Time frame: 9 months

- Cardiac and non-cardiac death in both groups

The frequency of deaths in both study group will be presented with differentiation according to the primary cause of the event.

Time frame: 9 months

- Assessment of possibility vessel measurement and stent diameter/length choice based on this measurement performed in OCT (Optical Coherence Tomography)

The usefulness of OCT for stent choice will be analyzed. The frequency of procedures, when stent choice was done based on OCT measurements will be presented.