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

Coronary Artery Disease Clinical Trial

— CUT-DRESS  

Official title:

Cutting Balloon Predilation Prior to Abluminus Sirolimus-eluting Stent Implantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05801003
• Other study ID #: 529
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: February 2024
• Source: Hospital Universitario La Fe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: January 1, 2025
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

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

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Percutaneous Coronary Intervention

Intervention

Device:
• Predilation with cutting balloon.
PCI will be performed under OCT guidance. Predilation of the lesion will be done with cutting balloon.
• 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)

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital General de Valencia	Valencia
Spain	Hospital Universitario y Politécnico La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Fe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimum stent area post-stenting measured by optimal coherence tomography (OCT)		Immediately after the procedure
Secondary	Percentage of neointimal hyperplasia (%) measured by OCT coherence tomography (OCT).	Key secondary	9 month follow-up.
Secondary	Mean stent area measured by optimal coherence tomography		9 month follow-up.
Secondary	Acute procedural success		Immediately after the procedure
Secondary	Coronary disection		Immediately after the procedure
Secondary	Malapposition (Major/minor) post-stenting measured by optimal coherence tomography		Immediately after the procedure and at 9 month follow-up
Secondary	Mean neointimal hyperplasia area measured by optimal coherence tomography		9 months
Secondary	Minimum stent eccentricity measured by optimal coherence tomography		9 months
Secondary	Stent asymmetry index measured by optimal coherence tomography		9 months
Secondary	All cause death		12 months
Secondary	Death from cardiovascular causes		12 months
Secondary	Target vessel myocardial infarction		12 months
Secondary	Target lesion revascularization		12 months
Secondary	Stent thrombosis		12 months
Secondary	Any myocardial infarction		12 months