An interventional study of Predilation with cutting balloon. and Predilation with conventional balloon in Coronary Artery Disease, Percutaneous Coronary Intervention and Cutting Balloon, sponsored by Hospital Universitario La Fe. Recruiting at 3 sites in Spain. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-03-01.
Sponsored by Hospital Universitario La Fe · Not applicable, Interventional, and Treatment
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
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 96 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Hospital Universitario La Fe is the lead sponsor of 37 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Pre-dilation with cutting balloon followed by ASES implantation.
Device: Predilation with cutting balloon.
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 cutting balloon.
Also known as: Wolverine Cutting balloon
PCI will be performed under OCT guidance. Predilation of the lesion will be done with conventional balloon (semi-compliant or non-compliant)
Minimum stent area post-stenting measured by optimal coherence tomography (OCT)
Time frame: Immediately after the procedure
Percentage of neointimal hyperplasia (%) measured by OCT coherence tomography (OCT).
Key secondary
Time frame: 9 month follow-up.
Mean stent area measured by optimal coherence tomography
Time frame: 9 month follow-up.
Acute procedural success
Time frame: Immediately after the procedure
Coronary disection
Time frame: Immediately after the procedure
Malapposition (Major/minor) post-stenting measured by optimal coherence tomography
Time frame: Immediately after the procedure and at 9 month follow-up
Mean neointimal hyperplasia area measured by optimal coherence tomography
Time frame: 9 months
Minimum stent eccentricity measured by optimal coherence tomography
Time frame: 9 months
Stent asymmetry index measured by optimal coherence tomography
Time frame: 9 months
All cause death
Time frame: 12 months
Death from cardiovascular causes
Time frame: 12 months
Target vessel myocardial infarction
Time frame: 12 months
Target lesion revascularization
Time frame: 12 months
Stent thrombosis
Time frame: 12 months
Any myocardial infarction
Time frame: 12 months
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Hospital Universitario La Fe