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

NCT05801003 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2024-03-01

No results posted yet for this study

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

Conditions

Interventions

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)

Sponsors & Collaborators

  • Hospital Universitario La Fe

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2024-04-01
Completion
2025-01-01

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05801003 on ClinicalTrials.gov