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

NCT ID: NCT03529006

Last Updated: 2018-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2020-06-30

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).

Conditions

In-stent Restenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sequent Please Drug Coated Balloon Group

For Sequent Please Group, PCI (percutaneous coronary intervention) PCI procedure with Sequent Please inflation will be performed - drug eluting balloon will be used in the narrowed part of the artery. This method of treatment is one of the standard ones, which is typically used for treatment patients with diagnosis of in stent restenosis, the exact intervention and anesthesia procedures will be performed according to physician's usual practice. For bailout situation Xience stent implantation is possible.

Group Type: ACTIVE_COMPARATOR

Sequent Please inflation

Intervention Type: PROCEDURE

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

Absorb Stent Group

Absorb scaffold group will be treated by PCI procedure with Absorb BVS implantation - implantation of bioresorbable vascular scaffold (Absorb). Coronary stent implantation for treatment in stent restenosis is one of the standard method of treatment this disease, but Absorb system has not been investigated in this indication yet.

Group Type: ACTIVE_COMPARATOR

Absorb BVS implantation

Intervention Type: PROCEDURE

PCI procedure for treatment of ISR with Absorb BVS implantation

Interventions

Sequent Please inflation

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

Intervention Type: PROCEDURE

Absorb BVS implantation

PCI procedure for treatment of ISR with Absorb BVS implantation

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Luzerner Kantonsspital

OTHER

Sponsor Role: lead

Responsible Party

Wojciech Zasada

Clinical Trial Administrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Florim Cuculi

Role: PRINCIPAL_INVESTIGATOR

Luzerner Kantonsspital

Other Identifiers

AbsorbISR

Identifier Type: -

Identifier Source: org_study_id