NCT03893396

Safety Assessment of Angioplasty Procedures

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 983 (actual)
• Sponsor: Groupe Hospitalier de la Rochelle Ré Aunis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Angiospastic; Disorder

Interventions

Type	Name	Description
DEVICE	Coronary angioplasty	Procedure used to open clogged heart arteries. Involves the insertion of a tiny balloon and/or a stent to widen the artery.

Timeline

• Start date: 2019-04-01
• Primary completion: 2021-03-30
• Completion: 2023-04-30
• First posted: 2019-03-28
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: France