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

NCT03529006 | Unknown

• 1 other identifier: AbsorbISR
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

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).

Conditions

In-stent Restenosis

Keywords

bioresorbable vascular scaffold; drug eluting balloon

Outcome Measures

Primary Outcomes (1)

• Angiographic late lumen loss at 9 months

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

  9 months

Secondary Outcomes (20)

• - 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 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

• - 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

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

  9 months

Study Arms (2)

Sequent Please Drug Coated Balloon Group

ACTIVE COMPARATOR

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.

Procedure: Sequent Please inflation

Absorb Stent Group

ACTIVE COMPARATOR

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.

Procedure: Absorb BVS implantation

Interventions

Sequent Please inflation PROCEDURE

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

Sequent Please Drug Coated Balloon Group

Absorb BVS implantation PROCEDURE

PCI procedure for treatment of ISR with Absorb BVS implantation

Absorb Stent Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Luzerner Kantonsspital: lead

Study Officials

• Florim Cuculi

  Luzerner Kantonsspital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Trial Administrator

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 18, 2018
• Study Start: March 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: June 1, 2020
• Last Updated: May 18, 2018

Record last verified: 2018-05