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Drug-Eluting Balloon in Stable and Unstable Angina

NCT01781546 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2018-01-30

No results posted yet for this study

Summary

The purpose of this study is to compare DEB with BMS in CAD patients who are at high risk of bleeding and in whom the use of DES is therefore avoided. Our hypothesis is that PCI with DEB is non-inferior to BMS in the treatment of stable CAD or in ACS (UAP or NSTEMI) in patients at high risk of bleeding.

Conditions

Interventions

PROCEDURE

drug-eluting balloon (DEB)

The length of the DEB is chosen so that the lesion and 2mm from both ends are covered by the DEB. If needed, several DEBs can be used to cover the whole lesion. The diameter of the DEB and the pressure used is chosen so that the balloon-artery -ratio is 0.8-1.0. In case of a flow limiting dissection, significant recoil or coronary perforation, a provisional BMS is implanted (stent-artery -ratio 1.1) and the post dilatation is performed if indicated (the lesion length is \>20mm or stent malapposition is suspected).

PROCEDURE

bare-metal stent (BMS)

The BMS is implanted after predilatation (stent-artery -ratio 1.1) to cover the whole lesion and the postdilatation is performed if indicated (the lesion length \>20mm or stent malapposition is suspected).

Sponsors & Collaborators

  • Kuopio University Hospital

    collaborator OTHER

  • University of Helsinki

    collaborator OTHER

  • Turku University Hospital

    collaborator OTHER_GOV

  • Central Hospital of Lapland, Finland

    collaborator UNKNOWN

  • North Karelia Central Hospital

    lead OTHER

Principal Investigators

  • Tuomas Rissanen, MD, PhD · North Karelia Central Hospital

  • Antti Siljander, MD · North Karelia Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-22
Primary Completion
2018-01-16
Completion
2018-01-16

Countries

  • Finland

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 NCT01781546 on ClinicalTrials.gov