Safety Assessment of Angioplasty Procedures (SCRAP)

Groupe Hospitalier de la Rochelle Ré Aunis

Status: Completed

Conditions: Angiospastic; Disorder

Treatments: Device: Coronary angioplasty

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03893396

2018/P02/283

Details and patient eligibility

About

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.

Full 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.

Enrollment: 983 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design