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

Last updated: February 28, 2024
Sponsor: Hospital Universitario La Fe
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thrombosis

Chest Pain

Heart Disease

Treatment

Predilation with conventional balloon

Predilation with cutting balloon.

Clinical Study ID

NCT05801003
529
  • Ages 18-99
  • All Genders

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Total Participants: 96
Treatment Group(s): 2
Primary Treatment: Predilation with conventional balloon
Phase:
Study Start date:
February 01, 2023
Estimated Completion Date:
January 01, 2025

Study 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.

Connect with a study center

  • Hospital de la Santa Creu i Sant Pau

    Barcelona,
    Spain

    Site Not Available

  • Hospital General de Valencia

    Valencia,
    Spain

    Site Not Available

  • Hospital Universitario y Politécnico La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.