NCT05410678

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2015

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

6.6 years

First QC Date

June 4, 2022

Last Update Submit

June 7, 2022

Conditions

Coronary Artery Ectasia

Outcome Measures

Primary Outcomes (1)

  • primary endpoints

    Rate of myocardial infarction and cardiovascular mortality

    2 year

Secondary Outcomes (1)

  • secondary endpoints

    2 year

Study Arms (2)

renal stent group

EXPERIMENTAL

Acute coronary patients treatment with renal stent

Drug: Renal stent

BMCS group

ACTIVE COMPARATOR

Acute coronary patients treatment with bare-metal stent

Drug: Renal stent

Interventions

Renal stentDRUG

renal stent implantation in ectatic/aneurysmatic coronary arteries

Also known as: Renal stent for coronary artery
BMCS grouprenal stent group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute coronary syndrome patients
  • year age
  • ectatic/aneurysmatic coronary arteries

You may not qualify if:

  • Patients who underwent elective procedures,
  • experienced unsuccessful attempts
  • referred to surgical revascularization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 38299468DERIVED

MeSH Terms

Conditions

Coronary Aneurysm

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesAneurysmVascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

June 4, 2022

First Posted

June 8, 2022

Study Start

June 1, 2015

Primary Completion

January 1, 2022

Study Completion

April 1, 2022

Last Updated

June 8, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share