NCT03893396: SCRAP

Safety Assessment of Angioplasty Procedures

Completed Results posted Last updated 19 September 2024

What this trial tests

trial testing Coronary angioplasty in Angiospastic; Disorder in 983 participants. Completed in 30 April 2023.

Timeline

1 April 2019

Primary endpoint
30 March 2021

30 April 2023

Quick facts

Lead sponsor	Groupe Hospitalier de la Rochelle Ré Aunis
Status	Completed
Study type	OBSERVATIONAL
Enrollment	983
Start date	1 April 2019
Primary completion	30 March 2021
Estimated completion	30 April 2023
Sites	1 location across France

Drugs / interventions tested

• Coronary angioplasty

Conditions studied

• Angiospastic; Disorder — all drugs for Angiospastic; Disorder →

Sponsor

Groupe Hospitalier de la Rochelle Ré Aunis

Who can join

18 and older, any sex, with Angiospastic; Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Major Adverse Cardiac Events (MACE) Primary · 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.

Group	Value	95% CI
c-DES	9
BO-DES	6
DCB-only	2
c-DES	119
BO-DES	254
DCB-only	509
c-DES	10
BO-DES	21
DCB-only	19

Number of Major Adverse Cardiac Events (MACE) Secondary · 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.

Group	Value	95% CI
c-DES	94
BO-DES	218
DCB-only	438
c-DES	24
BO-DES	44
DCB-only	61

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to three year after percutaneous coronary intervention. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

c-DES

Serious: 9/143 (6%)

Deaths: 26/143

BO-DES

Serious: 19/294 (6%)

Deaths: 31/294

DCB-only

Serious: 22/546 (4%)

Deaths: 43/546

Serious adverse events (3 terms)

Reaction	System	c-DES	BO-DES	DCB-only
Coronary restenosis	Cardiac disorders	—	—	—
Stroke	Nervous system disorders	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—

Most-reported serious reactions: Coronary restenosis, Stroke, Myocardial infarction.

Data from ClinicalTrials.gov NCT03893396 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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).
   Meunier L, Godin M, Souteyrand G, Mottin B, et al · · 2023 · cited 4× · PMID 35776144 · DOI 10.1007/s00392-022-02054-7
2. 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.
   Meunier L, Eccleshall S, Bakdi R, Godin M, et al · · 2025 · cited 3× · PMID 40745698 · DOI 10.1002/clc.70189