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SCRAP: Safety Assessment of Angioplasty Procedures

Sponsor
Groupe Hospitalier de la Rochelle Ré Aunis (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03893396
Collaborator
BBraun Medical SAS (Industry)
984
Enrollment
1
Location
47.9
Anticipated Duration (Months)
20.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
984 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Safety Assessment of Angioplasty Procedures
Actual Study Start Date :
Apr 1, 2019
Actual Primary Completion Date :
Mar 30, 2021
Anticipated Study Completion Date :
Mar 30, 2023

Outcome Measures

Primary Outcome Measures

  1. Number of major adverse cardiac events (MACE) [12 months]

    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.

Secondary Outcome Measures

  1. Number of major adverse cardiac events (MACE) [36 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Groupe Hospitalier de la Rochelle Ré Aunis La Rochelle France

Sponsors and Collaborators

  • Groupe Hospitalier de la Rochelle Ré Aunis
  • BBraun Medical SAS

Investigators

  • Study Director: Ludovic MEUNIER, MD, Groupe Hospitalier de la Rochelle Ré Aunis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Groupe Hospitalier de la Rochelle Ré Aunis
ClinicalTrials.gov Identifier:
NCT03893396
Other Study ID Numbers:
  • 2018/P02/283
First Posted:
Mar 28, 2019
Last Update Posted:
Jul 8, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Groupe Hospitalier de la Rochelle Ré Aunis
drug eluting stent
Drug-coated balloon
Bare-Metal Stent
Revascularization

Study Results

No Results Posted as of Jul 8, 2022