Safety Assessment of Angioplasty Procedures

Angiospastic; Disorder Clinical Trial

— SCRAP  

Official title:

Safety Assessment of Angioplasty Procedures

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03893396
• Other study ID #: 2018/P02/283
• Status: Active, not recruiting
• Start date: April 1, 2019
• Est. completion date: March 30, 2023

Study information

• Verified date: July 2022
• Source: Groupe Hospitalier de la Rochelle Ré Aunis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 984
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Angiospastic; Disorder

Intervention

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.

Locations

Country	Name	City	State
France	Groupe Hospitalier de la Rochelle Ré Aunis	La Rochelle

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Rochelle Ré Aunis	BBraun Medical SAS

Country where clinical trial is conducted

France, 

References & Publications (1)

Meunier L, Godin M, Souteyrand G, Mottin B, Valy Y, Lordet V, Benoit C, Bakdi R, Laurençon V, Genereux P, Waliszewski M, Allix-Béguec C. Prospective, single-centre evaluation of the safety and efficacy of percutaneous coronary interventions following a de — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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