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

La Fe University and Polytechnic Hospital

Status: Enrolling

Conditions: Cutting Balloon; Coronary Artery Disease; Percutaneous Coronary Intervention

Treatments: Device: Predilation with cutting balloon.; Device: Predilation with conventional balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT05801003

529

Details and patient eligibility

About

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

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Study group

Experimental group

Description:

Pre-dilation with cutting balloon followed by ASES implantation.

Treatment:

Device: Predilation with cutting balloon.

Control group

Active Comparator group

Description:

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

Treatment:

Device: Predilation with conventional balloon