MedTrace Logo

Absorb BVS vs. Drug Coated Balloon for Treatment Of ISR

NCT02474485 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2018-03-09

No results posted yet for this study

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

Interventions

DEVICE

BVS Absorb implantation.

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

DEVICE

DEB Sequent Please inflation.

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

PROCEDURE

Control coronary angiography.

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

PROCEDURE

OCT visualization.

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

OTHER

Clinical observation.

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.

Sponsors & Collaborators

  • SIS Medical AG

    lead INDUSTRY

Principal Investigators

  • Florim Cuculi, Prof. dr

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-05-31
Completion
2021-06-30

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02474485 on ClinicalTrials.gov