Absorb BVS vs. Drug Coated Balloon for Treatment Of ISR

NCT02474485 | Suspended

• 1 other identifier: AbsorbISR
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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®.

Conditions

Coronary Artery Disease; Coronary Restenosis

Keywords

bioresorbable vascular scaffold; Absorb; drug eluting balloon; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• Angiographic late lumen loss at 9 month follow-up.

  Angiographic late lumen loss will be compared between both study groups.

  At 9 month follow up.

Secondary Outcomes (18)

• Incidence of periprocedural complications: unplanned use of GP IIb/IIIa inhibitors.

  Participants will be followed for the duration of index procedure, an expected average of 1 hour.

• Incidence of periprocedural complications: vessel rupture.

  Participants will be followed for the duration of index procedure, an expected average of 1 hour.

• Incidence of periprocedural complications: side branch occlusion.

  Participants will be followed for the duration of index procedure, an expected average of 1 hour.

• Incidence of periprocedural complications: peri-procedural myocardial infarction.

  Participants will be followed for the duration of index procedure, an expected average of 1 hour.

• 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)).

  Participants will be followed for the duration of index procedure, an expected average of 1 hour.

Study Arms (2)

BVS - Absorb

ACTIVE COMPARATOR

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.

Device: BVS Absorb implantation.; Procedure: Control coronary angiography.; Procedure: OCT visualization.; Other: Clinical observation.

DEB - Sequent Please

ACTIVE COMPARATOR

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.

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

Interventions

BVS Absorb implantation. DEVICE

Absorb bioresorbable vascular scaffold will be implanted to treat in stent restenosis in target vessel.

BVS - Absorb

DEB Sequent Please inflation. DEVICE

Inflation of drug eluting balloon Sequent Please will be performed to treat in stent restenosis in target vessel.

DEB - Sequent Please

Control coronary angiography. PROCEDURE

Control coronary angiography will be performed at 9 month follow-up.

BVS - Absorb; DEB - Sequent Please

OCT visualization. PROCEDURE

OCT visualization will be performed during index procedure and at 9 month follow-up.

BVS - Absorb; DEB - Sequent Please

Clinical observation. OTHER

Patients will be informed that Investigator will contact them at 12, 24 and 60 months after the procedure. Investigator will collect information regarding clinical status of Patients, cardiac medications and any adverse events that occurred since the last follow-up.

BVS - Absorb; DEB - Sequent Please

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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• SIS Medical AG: lead

Study Sites (1)

Luzernen Kantonsspital, Spitalstrasse 16

Lucerne, 6000, Switzerland

Location

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Restenosis

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Coronary Stenosis

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Florim Cuculi, Prof. dr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 17, 2015
• Study Start: March 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: June 1, 2021
• Last Updated: March 9, 2018

Record last verified: 2018-03

Locations

CH (1)