Safety Assessment of Angioplasty Procedures (SCRAP)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Angiospastic; Disorder
• Intervention / Treatment: Device: Coronary angioplasty

Detailed Description

The use of active stents for the treatment of coronary stenosis is currently the standard treatment in almost all types of coronary lesions. In percutaneous transluminal treatment of coronary lesions, balloon angioplasty and bare stents have not shown satisfactory results in the past. The so-called active drug-eluting balloon could represent a new therapeutic option for the treatment of de novo lesions.

• Study Type: Observational
• Enrollment (Actual): 984

Contacts and Locations

Study Locations

• France
  • La Rochelle, France
    • Groupe Hospitalier de la Rochelle Ré Aunis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Interventional revascularization of a coronary lesion,
• Member or beneficiary of a social security system,
• Informed of the study.

Exclusion Criteria:

• Language barrier,
• Minor,
• Pregnant woman,
• Person under guardianship,
• Person deprived of his/her liberty,
• Refusal to participate.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of major adverse cardiac events (MACE)	The secondary 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.	36 months

Collaborators and Investigators

• Sponsor: Groupe Hospitalier de la Rochelle Ré Aunis
• Collaborators: BBraun Medical SAS
• Investigators: Study Director: Ludovic MEUNIER, MD, Groupe Hospitalier de la Rochelle Ré Aunis

Publications and helpful links

General Publications

• 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. 2022 Jul 1. doi: 10.1007/s00392-022-02054-7. Online ahead of print. Erratum In: Clin Res Cardiol. 2022 Aug 4;:

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): March 30, 2021
• Study Completion (Anticipated): March 30, 2023

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (Actual): March 28, 2019

Study Record Updates

• Last Update Posted (Actual): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Revascularization; drug eluting stent; Drug-coated balloon; Bare-Metal Stent
• Other Study ID Numbers: 2018/P02/283

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Data will be made available with the free access to the publication for 15 years.
• IPD Sharing Access Criteria: Zenodo A Digital Object Identifier will be provided
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No