Absorb BVS vs. Drug Coated Balloon for Treatment Of ISR (AbsorbISR)

SIS Medical

Status: Suspended

Conditions: Coronary Artery Disease; Coronary Restenosis

Treatments: Other: Clinical observation.; Device: BVS Absorb implantation.; Device: DEB Sequent Please inflation.; Procedure: OCT visualization.; Procedure: Control coronary angiography.

Study type: Interventional

Funder types: Industry

Identifiers

NCT02474485

AbsorbISR

Details and patient eligibility

About

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®.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

BVS - Absorb

Active Comparator group

Description:

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.

Treatment:

Other: Clinical observation.

Procedure: OCT visualization.

Procedure: Control coronary angiography.

Device: BVS Absorb implantation.

DEB - Sequent Please

Active Comparator group

Description:

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.

Treatment:

Device: DEB Sequent Please inflation.

Other: Clinical observation.

Procedure: OCT visualization.

Procedure: Control coronary angiography.