N/A
N=983
Safety Assessment of Angioplasty Procedures
Angiospastic; Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03893396 ↗Enrolled (actual)
983
Serious AEs
5.1%
Results posted
Sep 2024
Primary outcome: Primary: Number of Major Adverse Cardiac Events (MACE) — 9; 6; 2; 119 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Coronary angioplasty (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Major Adverse Cardiac Events (MACE) |
94; 218; 438; 24; 44; 61 | — |
| SECONDARY Number of Major Adverse Cardiac Events (MACE) |
94; 218; 438; 24; 44; 61 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03893396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.