Long Term Outcomes Of Hybrid Percutaneous Approach

NCT ID: NCT03570762

Last Updated: 2018-06-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-01
• Study Completion Date: 2017-04-30

Brief Summary

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

hybrid percutaneous intervention

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• treated with BVS in combination with DES

Exclusion Criteria

• treated with only DES or BVS

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liv Hospital Ankara

OTHER

Sponsor Role: lead

Responsible Party

Erol Kalender

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

322157920101986

Identifier Type: -

Identifier Source: org_study_id