Long Term Outcomes Of Hybrid Percutaneous Approach

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03570762
• Other study ID #: 322157920101986
• Status: Completed
• Start date: February 1, 2015
• Est. completion date: April 30, 2017

Study information

• Verified date: June 2018
• Source: Liv Hospital Ankara
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 30, 2017
• Est. primary completion date: April 30, 2017
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• treated with BVS in combination with DES

Exclusion Criteria:

• treated with only DES or BVS

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• hybrid percutaneous intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Liv Hospital Ankara

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	target lesion failure	a composite of cardiac death, target vessel myocardial infarction and target lesion revascularization	2 year