Safety And Efficacy Results of Percutaneous Renal Stent Implantation in Ectatic and Aneurysmatic Coronary Arteries

Coronary Artery Ectasia Clinical Trial

Official title:

Safety And Efficacy Results of Percutaneous Renal Stent Implantation in Patients With Acute Coronary Syndrome With Ectatic and Aneurysmatic Coronary Arteries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05410678
• Other study ID #: SBU Bursa PH
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Coronary Aneurysm
• Coronary Artery Ectasia

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