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

Cutting Balloon Predilation Prior to Abluminus Sirolimus-eluting Stent Implantation

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

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; Cutting Balloon
• Intervention / Treatment: Device: Predilation with cutting balloon.; Device: Predilation with conventional balloon

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.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Not yet recruiting
    • Hospital De La Santa Creu I Sant Pau
    • Contact: Estefania Fernandez Peregrina
  • Valencia, Spain, 46026
    • Recruiting
    • Hospital Universitario y Politecnico La Fe
    • Contact: Jorge Sanz Sanchez, MD, PhD; Phone Number: 440087; Email: sjorge4@gmx.com
    • Sub-Investigator: Jose Luis Diez Gil, MD, PhD
  • Valencia, Spain
    • Not yet recruiting
    • Hospital General de Valencia
    • Contact: Eva Rumiz González, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; Pre-dilation with cutting balloon followed by ASES implantation.	Device: Predilation with cutting balloon.; PCI will be performed under OCT guidance. Predilation of the lesion will be done with cutting balloon.; Other Names: Wolverine Cutting balloon
Active Comparator: Control group; Pre-dilation with a standard balloon (semi-compliant or non-compliant) followed by ASES implantation.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Minimum stent area post-stenting measured by optimal coherence tomography (OCT)	Immediately after the procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Universitario La Fe

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: March 11, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 529

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No