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OpenTrials
Completed

NCT Number: NCT03893396

Safety Assessment of Angioplasty Procedures

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.

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Key information

Conditions

Angiospastic; Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier de la Rochelle Ré Aunis

La Rochelle, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coronary angioplasty

Device

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

Other names: Percutaneous coronary

Primary outcomes

  1. Number of Major Adverse Cardiac Events (MACE)

    Time frame: 12 months

    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.

Secondary outcomes

  1. Number of Major Adverse Cardiac Events (MACE)

    Time frame: 36 months

    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.

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de la Rochelle Ré Aunis

Other

Collaborators

  • BBraun Medical SAS

Registry information

Acronym: SCRAP

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Mar 28, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.