MedTrace Logo

Treatment of In-Stent Restenosis 2 Study

NCT03667313 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-12-07

No results posted yet for this study

Summary

The aim of this study is to compare the efficacy of sirolimus-eluting balloon catheters (SEB) and iopromide-coated paclutaxel-eluting balloon catheters (PEB) in the treatment of bare metal (BMS) - or drug-eluting stents restenosis (DES-ISR).

Conditions

  • Coronary Restenosis

Interventions

COMBINATION_PRODUCT

sirolimus-eluting balloon (SEB) MagicTouch

Patients with coronary in-stent restenosis treated with sirolimus-eluting balloon

COMBINATION_PRODUCT

paclitaxel-eluting balloon (PEB) Sequent Please

Patients with coronary in-stent restenosis treated with paclitaxel-eluting balloon

Sponsors & Collaborators

  • University Hospital Ostrava

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2021-11-30
Completion
2021-12-31

Countries

  • Czechia

Study Locations

More Related Trials

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 NCT03667313 on ClinicalTrials.gov