Clinical trial NCT05801003: Cutting Balloon Predilation Prior to Abluminus Sirolimus-eluting Stent Implantation (CUT-DRESS).
Official title: Cutting Balloon Predilation Prior to Abluminus Sirolimus-eluting Stent Implantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Percutaneous Coronary Intervention
Cutting Balloon
Lead sponsor: Hospital Universitario La Fe
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multicenter, randomized controlled trial
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Minimum stent area post-stenting measured by optimal coherence tomography (OCT)
timeFrame: Immediately after the procedure
Secondary outcomes:
measure: Percentage of neointimal hyperplasia (%) measured by OCT coherence tomography (OCT).
timeFrame: 9 month follow-up.
measure: Mean stent area measured by optimal coherence tomography
timeFrame: 9 month follow-up.
measure: Acute procedural success
timeFrame: Immediately after the procedure
measure: Coronary disection
timeFrame: Immediately after the procedure
measure: Malapposition (Major/minor) post-stenting measured by optimal coherence tomography
timeFrame: Immediately after the procedure and at 9 month follow-up
measure: Mean neointimal hyperplasia area measured by optimal coherence tomography
timeFrame: 9 months
measure: Minimum stent eccentricity measured by optimal coherence tomography
timeFrame: 9 months
measure: Stent asymmetry index measured by optimal coherence tomography
timeFrame: 9 months
measure: All cause death
timeFrame: 12 months
measure: Death from cardiovascular causes
timeFrame: 12 months
measure: Target vessel myocardial infarction
timeFrame: 12 months
measure: Target lesion revascularization
timeFrame: 12 months
measure: Stent thrombosis
timeFrame: 12 months
measure: Any myocardial infarction
timeFrame: 12 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
city: Valencia
country: Spain
facility: Hospital General de Valencia
Study officials:
References: