Angiospastic; DisorderSCRAPNCT03893396

Safety Assessment of Angioplasty Procedures

An observational study of Angiospastic; Disorder, run by Groupe Hospitalier de la Rochelle Ré Aunis at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Angiospastic; Disorder
What is being tested?: Coronary angioplasty
Type of treatment: Medical device
How many people: 983 participants
Where: 1 siteFrance
Study dates: 1 Apr 2019to 30 Apr 2023
How long will I take part?: 3 Years
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

Interventional revascularization of a coronary lesion,
Member or beneficiary of a social security system,
Informed of the study.

Who cannot join

Language barrier,
Minor,
Pregnant woman,
Person under guardianship,
Person deprived of his/her liberty,
Refusal to participate.

Trial locations and contacts

1 site in 1 country.

France1 site

Groupe Hospitalier de la Rochelle Ré Aunis
La Rochelle

Other trials in France

About this study

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.

Read the 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.

Conditions: Angiospastic; Disorder
Being tested: Coronary angioplasty
Keywords: drug eluting stent, Drug-coated balloon, Bare-Metal Stent, Revascularization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Coronary angioplastyDevice
Also called Percutaneous coronary
Procedure used to open clogged heart arteries. Involves the insertion of a tiny balloon and/or a stent to widen the artery.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months

Secondary outcomes (1)

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.
Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201930 Apr 2023

First posted28 Mar 2019
Study start1 Apr 2019
Primary completion30 Mar 2021
Study completion30 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Angiospastic; DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 983 participants (actual)
Target duration: 3 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT03893396
Sponsor's protocol ID: 2018/P02/283
Acronym: SCRAP
Status last verified: Apr 2024
First submitted: 26 Mar 2019
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 35776144
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.
PubMed 40745698

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety Assessment of Angioplasty Procedures
ClinicalTrials.gov ID: NCT03893396
Acronym / sponsor ID: SCRAP / 2018/P02/283
Conditions: Angiospastic; Disorder
Keywords: drug eluting stent, Drug-coated balloon, Bare-Metal Stent, Revascularization
Study type: Observational
Recruitment status: Completed
Enrolment: 983 participants (actual)
Lead sponsor: Groupe Hospitalier de la Rochelle Ré AunisUniversity, hospital or other
Collaborators: BBraun Medical SAS
Study start: 1 Apr 2019 (actual)
Primary completion: 30 Mar 2021 (actual)
Study completion: 30 Apr 2023 (actual)
First posted: 28 Mar 2019 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Target follow-up: 3 Years

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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

Key inclusion criteria (3 listed)

Interventional revascularization of a coronary lesion,
Member or beneficiary of a social security system,
Informed of the study.

Key exclusion criteria (6 listed)

Language barrier,
Minor,
Pregnant woman,
Person under guardianship,
Person deprived of his/her liberty,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Coronary angioplastyAlso: Percutaneous coronaryProcedure used to open clogged heart arteries. Involves the insertion of a tiny balloon and/or a stent to widen the artery.	Device	–

Primary outcome

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.

1 secondary outcome

Number of Major Adverse Cardiac Events (MACE)
Time frame: 36 months

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
c-DES	143	127
BO-DES	294	268
DCB-only	546	501

Primary outcome: Number of Major Adverse Cardiac Events (MACE)

Time frame: 12 months. Count of participants. Unit: Participants

Measure	c-DES n = 138	BO-DES n = 281	DCB-only n = 530
Number of in-hospital death following percutaneous coronary intervention	9	6	2
Number of participants without MACE	119	254	509
Number of participants who underwent MACE	10	21	19

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to three year after percutaneous coronary intervention. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
c-DES	9 of 143 (6.3%)	0 of 143 (0%)	26 of 143
BO-DES	19 of 294 (6.5%)	0 of 294 (0%)	31 of 294
DCB-only	22 of 546 (4%)	0 of 546 (0%)	43 of 546

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 35776144Meunier 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.
Derived from this study: PubMed 40745698Meunier 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.
Individual participant dataSharing planned: Yes. 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ludovic MEUNIER, MD study director

Groupe Hospitalier de la Rochelle Ré Aunis

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Angiospastic; Disorder, run by Groupe Hospitalier de la Rochelle Ré Aunis at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Major Adverse Cardiac Events (MACE) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03893396, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.