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| Name | Class |
|---|---|
| BBraun Medical SAS | INDUSTRY |
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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.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Ludovic MEUNIER, MD | Groupe Hospitalier de la Rochelle Ré Aunis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier de la Rochelle Ré Aunis | La Rochelle | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35776144 | Result | 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. | |
| 40745698 |
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Data will be made available with publication. A Digital Object Identifier will be used.
Keywords are Coronary Artery Disease, Percutaneous Coronary Intervention, Angioplasty, Drug-eluting stent, Drug-coated balloon, Patient Outcome Assessment.
The only available version will be the locked database. With the exception of dates, all data will be made available. Dates will only be collected to verify the quality of the clinical trial execution. They do not add to the clinical question, and may be a means of indirectly identifying patients. The database will be made available through Zenodo.
Medical Subject Headings (MESH) terms will be used to describe clinical data. International standard unit will be used. The data will be made available to the community of scientists and clinicians interested in percutaneous coronary intervention.
Data will be made available with the free access to the publication for 15 years.
A Digital Object Identifier will be provided
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| ID | Title | Description |
|---|---|---|
| FG000 | c-DES | If the patient was hemodynamically or rhythmically unstable, conventional drug-eluting stent (DES) angioplasty was performed |
| FG001 | BO-DES | Patients eligible for a stent-less strategy underwent lesion preparation with scoring balloon. In cases of persistent residual stenosis, dissection at high risk of acute occlusion, or dissection at risk of secondary aneurysmal, bailout stenting with DES was performed (BO-DES) |
| FG002 | DCB-only | Patients eligible for a stent-less strategy underwent lesion preparation with scoring balloon. If lesion preparation was successful, the second step of angioplasty was performed with drug-coated balloon (DCB). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | c-DES | If the patient was hemodynamically or rhythmically unstable, conventional drug-eluting stent (DES) angioplasty was performed |
| BG001 | BO-DES | Patients eligible for a stent-less strategy underwent lesion preparation with scoring balloon. In cases of persistent residual stenosis, dissection at high risk of acute occlusion, or dissection at risk of secondary aneurysmal, bailout stenting with DES was performed (BO-DES) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 12 months |
|
Up to three year after percutaneous coronary intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | c-DES | If the patient was hemodynamically or rhythmically unstable, conventional drug-eluting stent (DES) angioplasty was performed |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary restenosis | Cardiac disorders | MedDRA 24.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caroline Allix-Béguec, clinical research manager | Groupe Hospitalier de la Rochelle Ré Aunis | +33516494246 | caroline.allix-beguec@ght-atlantique17.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2021 | Aug 4, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000800 | Angioplasty, Balloon |
| ID | Term |
|---|---|
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
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| Derived |
| 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. |
| BG002 | DCB-only | Patients eligible for a stent-less strategy underwent lesion preparation with scoring balloon. If lesion preparation was successful, the second step of angioplasty was performed with drug-coated balloon (DCB). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Clinical presentation | Count of Participants | Participants |
|
| OG002 | DCB-only | Patients eligible for a stent-less strategy underwent lesion preparation with scoring balloon. If lesion preparation was successful, the second step of angioplasty was performed with DCB. |
|
|
| 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. | All consecutive patients in whom coronary angioplasty was performed, i.e. acute coronary syndrome non-ST myocardial infarction (NSTEMI) or ST myocardial infarction (STEMI), chronic coronary syndrome including angina, silent ischemia, ischemic heart disease, were eligible. The exclusion criteria were patients <18 years of age, pregnancy, legally protected patients or deprived of liberty, and refusal to participate. In-hospital deaths following percutaneous coronary intervention were excluded. | Posted | Count of Participants | Participants | 36 months |
|
|
|
| 26 |
| 143 |
| 9 |
| 143 |
| 0 |
| 143 |
| EG001 | BO-DES | Patients eligible for a stent-less strategy underwent lesion preparation with scoring balloon. In cases of persistent residual stenosis, dissection at high risk of acute occlusion, or dissection at risk of secondary aneurysmal, bailout stenting with DES was performed (BO-DES) | 31 | 294 | 19 | 294 | 0 | 294 |
| EG002 | DCB-only | Patients eligible for a stent-less strategy underwent lesion preparation with scoring balloon. If lesion preparation was successful, the second step of angioplasty was performed with DCB. | 43 | 546 | 22 | 546 | 0 | 546 |
| Stroke | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
|
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| D014656 |
| Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
| Male |
|
| Non-ST-Elevation Myocardial Infarction (NSTEMI) |
|
| Chronic coronary syndrome |
|