Safety Assessment of Angioplasty Procedures
SCRAP
1 other identifier
observational
983
1 country
1
Brief Summary
Ischemic heart disease, or coronary heart disease, covers a set of pathologies due to insufficient oxygen supply to the myocardium due to the development of atherosclerosis in one or more coronary arteries. To evaluate the safety of angioplasty performed in patients operated on at La Rochelle Hospital, the rate of major adverse cardiac events (MACE) will be determined and compared with data from the literature.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2019
Longer than P75 for all trials
1 active site
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
First Submitted
Initial submission to the registry
March 26, 2019
CompletedFirst Posted
Study publicly available on registry
March 28, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedResults Posted
Study results publicly available
September 19, 2024
CompletedSeptember 19, 2024
April 1, 2024
2 years
March 26, 2019
August 4, 2023
April 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Major Adverse Cardiac Events (MACE)
The primary endpoint is a composite endpoint that includes major adverse cardiac events defined as cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke (stroke) and revascularization of target lesion (TLR) within 12 months of surgery.
12 months
Secondary Outcomes (1)
Number of Major Adverse Cardiac Events (MACE)
36 months
Interventions
Procedure used to open clogged heart arteries. Involves the insertion of a tiny balloon and/or a stent to widen the artery.
Eligibility Criteria
Patients referred for coronary angiography for revascularization are those for whom a diagnosis of acute (Acute Coronary Syndrome with or without ST segment elevation) or chronic (Silent myocardial ischemia, angina) coronary pathology has been made
You may qualify if:
- Interventional revascularization of a coronary lesion,
- Member or beneficiary of a social security system,
- Informed of the study.
You may not qualify if:
- Language barrier,
- Minor,
- Pregnant woman,
- Person under guardianship,
- Person deprived of his/her liberty,
- Refusal to participate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Groupe Hospitalier de la Rochelle Ré Aunislead
- BBraun Medical SAScollaborator
Study Sites (1)
Groupe Hospitalier de la Rochelle Ré Aunis
La Rochelle, France
Related Publications (2)
Meunier L, Godin M, Souteyrand G, Mottin B, Valy Y, Lordet V, Benoit C, Bakdi R, Laurencon V, Genereux P, Waliszewski M, Allix-Beguec C. Prospective, single-centre evaluation of the safety and efficacy of percutaneous coronary interventions following a decision tree proposing a no-stent strategy in stable patients with coronary artery disease (SCRAP study). Clin Res Cardiol. 2023 Sep;112(9):1164-1174. doi: 10.1007/s00392-022-02054-7. Epub 2022 Jul 1.
PMID: 35776144RESULTMeunier L, Eccleshall S, Bakdi R, Godin M, Souteyrand G, Mottin B, Valy Y, Benoit C, Lordet V, Laurencon V, Milhem A, Waliszewski M, Allix-Beguec C. Long-Term Effectiveness of a Stent-Less Strategy With Drug Coated Balloon in Coronary Artery Disease: 3-Year Follow-Up of a Prospective All-Comers Observational Study. Clin Cardiol. 2025 Aug;48(8):e70189. doi: 10.1002/clc.70189.
PMID: 40745698DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Caroline Allix-Béguec, clinical research manager
- Organization
- Groupe Hospitalier de la Rochelle Ré Aunis
Study Officials
- STUDY DIRECTOR
Ludovic MEUNIER, MD
Groupe Hospitalier de la Rochelle Ré Aunis
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2019
First Posted
March 28, 2019
Study Start
April 1, 2019
Primary Completion
March 30, 2021
Study Completion
April 30, 2023
Last Updated
September 19, 2024
Results First Posted
September 19, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be made available with the free access to the publication for 15 years.
- Access Criteria
- A Digital Object Identifier will be provided
Data will be made available with publication. A Digital Object Identifier will be used. Keywords are Coronary Artery Disease, Percutaneous Coronary Intervention, Angioplasty, Drug-eluting stent, Drug-coated balloon, Patient Outcome Assessment. The only available version will be the locked database. With the exception of dates, all data will be made available. Dates will only be collected to verify the quality of the clinical trial execution. They do not add to the clinical question, and may be a means of indirectly identifying patients. The database will be made available through Zenodo. Medical Subject Headings (MESH) terms will be used to describe clinical data. International standard unit will be used. The data will be made available to the community of scientists and clinicians interested in percutaneous coronary intervention.