Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-25 @ 4:54 PM
Study NCT ID:
NCT05801003
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2023-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cutting Balloon Predilation Prior to Abluminus Sirolimus-eluting Stent Implantation (CUT-DRESS).
Sponsor:
Hospital Universitario La Fe
Organization:
Study Overview
Official Title:
Cutting Balloon Predilation Prior to Abluminus Sirolimus-eluting Stent Implantation
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CUT-DRESS
Brief 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
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: