Safety And Efficacy Results of Percutaneous Renal Stent Implantation in Ectatic and Aneurysmatic Coronary Arteries
June 7, 2022 updated by: Hasan ARI, Bursa Postgraduate Hospital
Safety And Efficacy Results of Percutaneous Renal Stent Implantation in Patients With Acute Coronary Syndrome With Ectatic and Aneurysmatic Coronary Arteries
The aim of this study was to evaluate the efficacy and safety of renal stents implanted in ectatic/aneurysmatic coronary arteries.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
63
Phase
- Phase 4
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: renal stent group
Acute coronary patients treatment with renal stent
|
renal stent implantation in ectatic/aneurysmatic coronary arteries
Other Names:
|
|
Active Comparator: BMCS group
Acute coronary patients treatment with bare-metal stent
|
renal stent implantation in ectatic/aneurysmatic coronary arteries
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
primary endpoints
Time Frame: 2 year
|
Rate of myocardial infarction and cardiovascular mortality
|
2 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
secondary endpoints
Time Frame: 2 year
|
Rate of restenosis and all-cause mortality
|
2 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
June 1, 2015
Primary Completion (Actual)
January 1, 2022
Study Completion (Actual)
April 1, 2022
Study Registration Dates
First Submitted
June 4, 2022
First Submitted That Met QC Criteria
June 7, 2022
First Posted (Actual)
June 8, 2022
Study Record Updates
Last Update Posted (Actual)
June 8, 2022
Last Update Submitted That Met QC Criteria
June 7, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBU Bursa PH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.