Safety Assessment of Angioplasty Procedures

• Conditions: Angiospastic; Disorder

• Registration Number: NCT03893396
• Lead Sponsor: Groupe Hospitalier de la Rochelle Ré Aunis

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.

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 Timeline

• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-28
• Study Start: 2019-04-01
• Primary Completion: 2021-03-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-06
• Last Update Posted: 2022-07-08
• Study Completion: 2023-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 984

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Groupe Hospitalier de la Rochelle Ré Aunis; 🇫🇷 La Rochelle, France