Long Term Outcomes Of Hybrid Percutaneous Approach

June 26, 2018 updated by: Erol Kalender, Liv Hospital Ankara

Long Term Outcomes Of Hybrid Percutaneous Intervention With Bioresorbable Vascular Scaffolds And Drug Eluting Stents For Complex Coronary Artery Lesions

Bioresorbable vascular scaffolds (BVS) are considered as a new revolution in coronary intervention due to their potential advantages for long term follow up. However, current generation BVS have also some drawbacks that restrict the use for complex lesions. Using BVS and drug eluting stents (DES) together -implanting DES for BVS inappropriate segments -may be a feasible option to avoid the disadvantages of permanent foreign body and to reduce very late adverse events. In this context, we investigated the clinical outcomes following treatment with hybrid strategy with concomitant use of BVS and DES for complex lesions. A single center retrospective cohort was performed enrolling 40 patients with complex lesions treated with hybrid approach from February 2015 up to April 2017. Lesion segments with a large plaque burden and/or severe calcification, aorto-ostial and bifurcation lesions that may be unfavorable for BVS, treated with DES. BVS and DES were implanted with minimal overlap of DES and BVS struts. The primary end-point was target lesion failure (TLF) which was a composite of cardiac death, target vessel myocardial infarction and target lesion revascularization (TLR). During follow-up, coronary angiography was performed when patients had ischemic symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

cardiology clinic

Description

Inclusion Criteria:

  • treated with BVS in combination with DES

Exclusion Criteria:

  • treated with only DES or BVS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
target lesion failure
Time Frame: 2 year
a composite of cardiac death, target vessel myocardial infarction and target lesion revascularization
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liv Hospital Ankara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

April 30, 2017

Study Completion (Actual)

April 30, 2017

Study Registration Dates

First Submitted

June 18, 2018

First Submitted That Met QC Criteria

June 18, 2018

First Posted (Actual)

June 27, 2018

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 322157920101986

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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