NCT05801003

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

Cutting Balloon Predilation Prior to Abluminus Sirolimus-eluting Stent Implantation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Hospital Universitario La Fe · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease
• Percutaneous Coronary Intervention
• Cutting Balloon

Interventions

Type	Name	Description
DEVICE	Predilation with cutting balloon.	PCI will be performed under OCT guidance. Predilation of the lesion will be done with cutting balloon.
DEVICE	Predilation with conventional balloon	PCI will be performed under OCT guidance. Predilation of the lesion will be done with conventional balloon (semi-compliant or non-compliant)

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-04-01
• Completion: 2025-01-01
• First posted: 2023-04-06
• Last updated: 2024-03-01

Locations

3 sites across 1 country: Spain