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Trial record 12 of 89 for:    Recruiting, Not yet recruiting, Available Studies | Angioplasty

Safety Assessment of Angioplasty Procedures (SCRAP)

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ClinicalTrials.gov Identifier: NCT03893396
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
BBraun Medical SAS
Information provided by (Responsible Party):
Groupe Hospitalier de la Rochelle Ré Aunis

Brief 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.

Condition or disease Intervention/treatment
Angiospastic; Disorder Device: Coronary angioplasty

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Year
Official Title: Safety Assessment of Angioplasty Procedures
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty


Intervention Details:
  • 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.
    Other Name: Percutaneous coronary


Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred for coronary angiography for revascularization are those for whom a diagnosis of acute (Acute Coronary Syndrome with or without ST segment elevation) or chronic (Silent myocardial ischemia, angina) coronary pathology has been made
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03893396


Contacts
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Contact: Caroline ALLIX-BEGUEC, Ph.D. +33 (0) 516 49 42 46 caroline.allix-beguec@ght-atlantique17.fr

Locations
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France
Groupe Hospitalier de la Rochelle Ré Aunis Recruiting
La Rochelle, France
Contact: Virginie LAURENCON    +33 5 46 45 50 50    virginie.laurencon@ght-atlantique17.fr   
Principal Investigator: Ludovic MEUNIER, MD         
Sub-Investigator: Yann VALY, MD         
Sub-Investigator: Benoît MOTTIN, MD         
Sponsors and Collaborators
Groupe Hospitalier de la Rochelle Ré Aunis
BBraun Medical SAS
Investigators
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Study Director: Ludovic MEUNIER, MD Groupe Hospitalier de la Rochelle Ré Aunis

Additional Information:

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Responsible Party: Groupe Hospitalier de la Rochelle Ré Aunis
ClinicalTrials.gov Identifier: NCT03893396     History of Changes
Other Study ID Numbers: 2018/P02/283
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Groupe Hospitalier de la Rochelle Ré Aunis:
drug eluting stent
Drug-coated balloon
Bare-Metal Stent
Revascularization