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Drug Coated Balloon Compared to Bare Metal Stent for de Novo Coronary Artery Lesions

NCT02456402 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-04-03

No results posted yet for this study

Summary

This randomized trial will assess the efficacy of Drug Coated Balloon (DCB) compared to Bare Metal Stent (BMS) using Fractional Flow Reserve (FFR) guidance for de novo coronary artery lesions in patients unable to tolerate dual antiplatelet therapy and at high risk of bleeding. Patients will be randomized after balloon angioplasty to receive either DCB or BMS. Endpoints are late luminal loss at 9 months, and major adverse cardiac events including arterial thrombosis at 1, 9 and 12 months.

Conditions

  • Stable Angina
  • Unstable Angina

Interventions

DEVICE

Drug Coated Balloon

If post balloon angioplasty FFR is more than 0.80, either DCB treatment or BMS implantation will be carried out based on randomization of 1:1. DCB (SeQuent Please paclitaxel-coated balloon catheter, B. Braun, Melsungen, Germany) will be applied at the predilated lesions. PCB will be delivered rapidly and inflated for 60 seconds with nominal pressure.

DEVICE

Bare Metal Stent

BMS (Vision®) will be applied at the predilated lesions after angiographic confirmation of the target lesion.

Sponsors & Collaborators

  • Seoul National University Hospital

    collaborator OTHER

  • Ulsan University Hospital

    lead OTHER

Principal Investigators

  • Eun-Seok Shin, M.D., PhD. · Ulsan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • South Korea

Study Locations

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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 NCT02456402 on ClinicalTrials.gov