Safety Assessment of Angioplasty Procedures

NCT ID: NCT03893396

Last Updated: 2024-09-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

983 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2023-04-30

Brief Summary

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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

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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

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Angiospastic; Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Coronary angioplasty

Procedure used to open clogged heart arteries. Involves the insertion of a tiny balloon and/or a stent to widen the artery.

Intervention Type DEVICE

Other Intervention Names

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Percutaneous coronary

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BBraun Medical SAS

INDUSTRY

Sponsor Role collaborator

Groupe Hospitalier de la Rochelle Ré Aunis

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ludovic MEUNIER, MD

Role: STUDY_DIRECTOR

Groupe Hospitalier de la Rochelle Ré Aunis

Locations

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Groupe Hospitalier de la Rochelle Ré Aunis

La Rochelle, , France

Site Status

Countries

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France

References

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Meunier L, Godin M, Souteyrand G, Mottin B, Valy Y, Lordet V, Benoit C, Bakdi R, Laurencon V, Genereux P, Waliszewski M, Allix-Beguec C. Prospective, single-centre evaluation of the safety and efficacy of percutaneous coronary interventions following a decision tree proposing a no-stent strategy in stable patients with coronary artery disease (SCRAP study). Clin Res Cardiol. 2023 Sep;112(9):1164-1174. doi: 10.1007/s00392-022-02054-7. Epub 2022 Jul 1.

Reference Type RESULT
PMID: 35776144 (View on PubMed)

Meunier L, Eccleshall S, Bakdi R, Godin M, Souteyrand G, Mottin B, Valy Y, Benoit C, Lordet V, Laurencon V, Milhem A, Waliszewski M, Allix-Beguec C. Long-Term Effectiveness of a Stent-Less Strategy With Drug Coated Balloon in Coronary Artery Disease: 3-Year Follow-Up of a Prospective All-Comers Observational Study. Clin Cardiol. 2025 Aug;48(8):e70189. doi: 10.1002/clc.70189.

Reference Type DERIVED
PMID: 40745698 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2018/P02/283

Identifier Type: -

Identifier Source: org_study_id

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