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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05410678
Other study ID # SBU Bursa PH
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 1, 2015
Est. completion date April 1, 2022

Study information

Verified date June 2022
Source Bursa Postgraduate Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study was to evaluate the efficacy and safety of renal stents implanted in ectatic/aneurysmatic coronary arteries.


Description:

In total, 18 patients (renal stent group) who underwent renal stent implantation in ectatic/aneurysmatic coronary arteries requiring percutaneous coronary intervention (PCI) and 45 patients who underwent large-sized bare metal coronary stent (BMCS) implantation (BMCS group) at our centre between 2015 and 2020 were included in the study. Control coronary angiography (CAG) was performed during the follow-up of these patients, and angiography-guided quantitative measurements were performed during PCI. The primary endpoints were myocardial infarction and cardiovascular mortality, and the secondary endpoints were restenosis and all-cause mortality.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date April 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Acute coronary syndrome patients - 18 year age - ectatic/aneurysmatic coronary arteries Exclusion Criteria: - Patients who underwent elective procedures, - experienced unsuccessful attempts - referred to surgical revascularization

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Renal stent
renal stent implantation in ectatic/aneurysmatic coronary arteries

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bursa Postgraduate Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary primary endpoints Rate of myocardial infarction and cardiovascular mortality 2 year
Secondary secondary endpoints Rate of restenosis and all-cause mortality 2 year
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