Cutting Balloon Predilation Prior to Abluminus Sirolimus-eluting Stent Implantation

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

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

Locations
Other Locations
Spain
Hospital de la Santa Creu i Sant Pau
NOT_YET_RECRUITING
Barcelona
Hospital General de Valencia
NOT_YET_RECRUITING
Valencia
Hospital Universitario y Politécnico La Fe
RECRUITING
Valencia
Time Frame
Start Date: 2023-02-01
Estimated Completion Date: 2025-01-01
Participants
Target number of participants: 96
Treatments
Experimental: Study group
Pre-dilation with cutting balloon followed by ASES implantation.
Active_comparator: Control group
Pre-dilation with a standard balloon (semi-compliant or non-compliant) followed by ASES implantation.
Sponsors
Leads: Hospital Universitario La Fe

This content was sourced from clinicaltrials.gov

Similar Clinical Trials