Coronary Artery EctasiaPhase 4NCT05410678
Safety And Efficacy Results of Percutaneous Renal Stent Implantation in Ectatic and Aneurysmatic Coronary Arteries
A Phase 4 study testing Renal stent in people with Coronary Artery Ectasia, run by Bursa Postgraduate Hospital.
Trial summary
The aim of this study was to evaluate the efficacy and safety of renal stents implanted in ectatic/aneurysmatic coronary arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Ectasia
- What is being tested?
- Renal stent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2015to 1 Apr 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute coronary syndrome patients
- 18 year age
- ectatic/aneurysmatic coronary arteries
Who cannot join
- Patients who underwent elective procedures,
- experienced unsuccessful attempts
- referred to surgical revascularization
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Ectasia
- Being tested
- Renal stent
- Medical subject headings
- Coronary Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal stentDrug
Also called Renal stent for coronary artery
renal stent implantation in ectatic/aneurysmatic coronary arteries
| Study group | Role | What they receive |
|---|---|---|
| renal stent group | Experimental | Acute coronary patients treatment with renal stent Receives: Drug: Renal stent |
| BMCS group | Active comparator | Acute coronary patients treatment with bare-metal stent Receives: Drug: Renal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary endpoints
Rate of myocardial infarction and cardiovascular mortality
Measured: 2 year
Secondary outcomes (1)
secondary endpoints
Rate of restenosis and all-cause mortality
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Jun 2015
- Primary completion1 Jan 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery EctasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Postgraduate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan ARI, Bursa Postgraduate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410678
- Sponsor's protocol ID
- SBU Bursa PH
- Status last verified
- Jun 2022
- First submitted
- 4 Jun 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Camci S, Ari H, Sunbul A, Ari S, Melek M, Bozat T. Safety and efficacy results of percutaneous renal stent implantation in patients with acute coronary syndrome with ectatic and aneurysmatic coronary arteries. Postgrad Med. 2024 Jan;136(1):95-102. doi: 10.1080/00325481.2024.2313447. Epub 2024 Feb 5.
PubMed 38299468
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety And Efficacy Results of Percutaneous Renal Stent Implantation in Patients With Acute Coronary Syndrome With Ectatic and Aneurysmatic Coronary Arteries
- ClinicalTrials.gov ID
- NCT05410678
- Acronym / sponsor ID
- SBU Bursa PH
- Conditions
- Coronary Artery Ectasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Bursa Postgraduate HospitalUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to evaluate the efficacy and safety of renal stents implanted in ectatic/aneurysmatic coronary arteries.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| renal stent group | Experimental | Drug: Renal stentAcute coronary patients treatment with renal stent |
| BMCS group | Active comparator | Drug: Renal stentAcute coronary patients treatment with bare-metal stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute coronary syndrome patients
- ectatic/aneurysmatic coronary arteries
Key exclusion criteria (3 listed)
- Patients who underwent elective procedures,
- experienced unsuccessful attempts
- referred to surgical revascularization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal stentAlso: Renal stent for coronary arteryrenal stent implantation in ectatic/aneurysmatic coronary arteries | Drug | BMCS group, renal stent group |
Primary outcome
primary endpoints
Time frame: 2 year
Rate of myocardial infarction and cardiovascular mortality
1 secondary outcome
secondary endpoints
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Derived from this study: PubMed 38299468Camci S, Ari H, Sunbul A, Ari S, Melek M, Bozat T. Safety and efficacy results of percutaneous renal stent implantation in patients with acute coronary syndrome with ectatic and aneurysmatic coronary arteries. Postgrad Med. 2024 Jan;136(1):95-102. doi: 10.1080/00325481.2024.2313447. Epub 2024 Feb 5.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Ectasia
RecruitingObservational study
Treatment of Primary Coronary Artery Vascular Lesions With Biolimus Coated Coronary Balloon Dilation Catheter
Coronary Artery Disease
RecruitingPhase 4
Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm After Kawasaki Disease
Kawasaki Disease, Pilot Study
RecruitingObservational study
Abbott Vascular Medical Device Registry
Acute Myocardial Infarction, Restenoses, Coronary
Recruiting
Impact of Stepwise Pressure-Increasing NC Balloon Post-Dilation on Stent Expansion
Coronary Artery Disease, Drug Eluting Stents
Not yet recruitingObservational study
Heart and Blood Vessels Health in People With Cystic Fibrosis
Cystic Fibrosis (CF), Cardiovascular (CV) Risk
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Renal stent in people with Coronary Artery Ectasia, run by Bursa Postgraduate Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary endpoints (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05410678, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.