Cutting Balloon Predilation Prior to Abluminus Sirolimus-eluting Stent Implantation (CUT-DRESS).

Not Applicable

Recruiting

• Conditions: Percutaneous Coronary Intervention; Coronary Artery Disease; Cutting Balloon
• Interventions: Device: Predilation with conventional balloon; Device: Predilation with cutting balloon.

• Registration Number: NCT05801003
• Lead Sponsor: Hospital Universitario La Fe

Brief Summary

Drug-eluting stents iterations has significantly improved the results of percutaneous revascularization among patients undergoing coronary revascularization thanks to thinner struts, more biocompatible polymer coatings and new drug release formulations; leading to lower thrombogenicity, faster reendothelialization and improved clinical outcomes. Notwithstanding, stent-related events yet occur.

Lesion pre-dilation prior to DES implantation is a crucial procedural step as it creates microdissections, which are required for optimal uptake of the drug. However, the best pre-dilation strategy has not yet been determined. Therefore, the aim of this study is to evaluate a strategy based on pre-dilation with cutting balloon (CB) followed by Abluminus Sirolimus-eluting stent (ASES) implantation for de novo coronary lesions

Detailed Description

The study will be a prospective, multicenter, randomized controlled trial in patients undergoing PCI with the novo coronary disease.

A total of 96 patients with de novo coronary artery stenosis will be included.

After being informed about the study and the potential risks, all patients meeting all the inclusion criteria and none of exclusion criteria will give written informed consent. Random allocation in a 1:1 fashion to one of the following strategies:

A) Study group: Pre-dilation with cutting balloon followed by ASES implantation.

B) Control group: Pre-dilation with a standard balloon (semi-compliant or non-compliant) followed by ASES implantation.

Stent optimisation will be performed based on intracoronary imaging findings.

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-03-11
• Study First Submitted QC: 2023-03-23
• Study First Posted: 2023-04-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-03-01
• Primary Completion: 2024-04-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Symptomatic coronary artery disease or evidence of ischemia in the presence of one or more coronary artery stenoses >50% in a native coronary artery.

Exclusion Criteria

1. Cardiogenic shock
2. Patients presenting with ST-segment elevation myocardial infarction
3. Patients undergoing chronic total occlusions PCI
4. Patients undergoing left main PCI
5. Patients undergoing venous bypass graft lesions PCI
6. Patients with in-stent restenosis
7. Inability to provide informed consent
8. Life expectancy <1year due to non-cardiac disease
9. Currently participating in another trial before reaching first endpoint

There will be no exclusion based on mode of co-morbidities, left ventricular function, number of diseased vessels and lesions, or number of target lesions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Predilation with conventional balloon	Pre-dilation with a standard balloon (semi-compliant or non-compliant) followed by ASES implantation.
Study group	Predilation with cutting balloon.	Pre-dilation with cutting balloon followed by ASES implantation.

Primary Outcome Measures

Name	Time	Method
Minimum stent area post-stenting measured by optimal coherence tomography (OCT)	Immediately after the procedure

Secondary Outcome Measures

Name	Time	Method
Percentage of neointimal hyperplasia (%) measured by OCT coherence tomography (OCT).	9 month follow-up.	Key secondary
Mean stent area measured by optimal coherence tomography	9 month follow-up.
Malapposition (Major/minor) post-stenting measured by optimal coherence tomography	Immediately after the procedure and at 9 month follow-up
Mean neointimal hyperplasia area measured by optimal coherence tomography	9 months
Death from cardiovascular causes	12 months
Target vessel myocardial infarction	12 months
Target lesion revascularization	12 months
Stent thrombosis	12 months
Acute procedural success	Immediately after the procedure
Coronary disection	Immediately after the procedure
Minimum stent eccentricity measured by optimal coherence tomography	9 months
Stent asymmetry index measured by optimal coherence tomography	9 months
All cause death	12 months
Any myocardial infarction	12 months

Trial Locations

Locations (3)

Hospital Universitario y Politécnico La Fe; 🇪🇸 Valencia, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital General de Valencia; 🇪🇸 Valencia, Spain