Cutting Balloon Predilation Prior to Abluminus Sirolimus-eluting Stent Implantation (CUT-DRESS).
NCT ID: NCT05801003
Last Updated: 2024-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
96 participants
INTERVENTIONAL
2023-02-01
2025-01-01
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Study group
Pre-dilation with cutting balloon followed by ASES implantation.
Predilation with cutting balloon.
PCI will be performed under OCT guidance. Predilation of the lesion will be done with cutting balloon.
Control group
Pre-dilation with a standard balloon (semi-compliant or non-compliant) followed by ASES implantation.
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)
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
18 Years
99 Years
ALL
No
Sponsors
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Hospital Universitario La Fe
OTHER
Responsible Party
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Jorge Sanz Sanchez
Specialist in Cardiology, MD, PhD
Locations
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Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario y Politécnico La Fe
Valencia, , Spain
Hospital General de Valencia
Valencia, , Spain
Countries
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Facility Contacts
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Estefania Fernandez Peregrina
Role: primary
Eva Rumiz González, MD, PhD
Role: primary
Other Identifiers
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529
Identifier Type: -
Identifier Source: org_study_id
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