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Clinical Trials in Spain / NCT06321757
Active, not recruiting Observational

PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients

NCT06321757 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2024-02-26
Last updated
2026-07-06

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Percutaneous Coronary Intervention with DCB and DAPT

Percutaneous Coronary Intervention with DCB and DAPT: * Patients with PCI (DCB) + standard DAPT standard dual antiplatelet therapy (DAPT) * Patients with PCI (DCB) + short DAPT

Study summary

Post-market, prospective, observational, multicenter, non-intervention study, to demonstrate the effectiveness of drug-coated ballon (DCB)therapy in real-world patients with small native vessel coronary artery disease, and to demonstrate the safety of short dual antiplatelet therapy (7 days) in high-bleeding risk patients with native small vessel coronary artery disease treated with DCB therapy. A percutaneous coronary intervention (PCI) with DCB will be performed in patients with native vessel coronary artery disease based on the criterion of the treating physician.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Patients with: * PCI with DCB on native arteries with diameters \< 3 mm. * Indication for PCI in acute coronary syndrome or chronic coronary syndrome or silent angina with an indication for PCI. syndrome or silent angina with an indication for PCI. * If previous lesion preparation was required after which angiographic residual lesion should not exist with diameter stenosis \> 30% or flow-limiting coronary dissections. * All antithrombotic therapies administered prior to the procedure are accepted. Still, they can be changed after the procedure. * Capacity to understand and sign the written informed consent. * If the patient has a high-bleeding risk defined by 1) PRECISE-DAPT SCORE ≥ 25 or 2) an indication for concomitant oral anticoagulation he can be included in the high- bleeding risk substudy as long as he does not meet the specific exclusion criteria. Exclusion Criteria: Patients with: * Concomitant lesions on vessels \> 3 mm in diameter in the same coronary territory. * PCI on in-stent restenoses. * PCI on culprit lesions of acute coronary syndrome with ST segment elevation. * Patients with an indication for PCI on additional non-culprit lesions of acute coronary syndrome with ST segment elevation may be included in the study, if only non-culprit lesions are considered for the study. * Life expectancy \<12 months * Pregnancy. * Participation in clinicaltrials. * Inability to give the written informed consent. * Specific exclusion criteria for the high-bleeding risk patient subgroup: * Past medical history of stent thrombosis. * Indication for dual antiplatelet therapy for a different reason.

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
Clinica Mediterranea Naples Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello Palermo Italy
Ulslo-H.Santa Cruz Carnaxide Portugal
ULS Santa Maria Lisbon Portugal
Hospital General Universitario de Albacete Albacete Spain
Hospital General Universitario Dr. Balmis Alicante Spain
Hospital Universitario de Cruces Barakaldo Spain
University Hospital HM Montepríncipe Boadilla del Monte Spain
Hospital General Universitario de Ciudad Real Ciudad Real Spain
Hospital Universitario Clinico San Cecilio Granada Spain
Hospital Universitario Juan Ramon Jimenez Huelva Spain
Hospital Universitari de Bellvitge L'Hospitalet de Llobregat Spain
Hospital Universitario de Gran Canaria Doctor Negrín Las Palmas de Gran Canaria Spain
Hospital Universitario de Leon León Spain
Hospital Universitario de La Princesa Madrid Spain
Hospital Universitario de Canarias San Cristóbal de La Laguna Spain
Hospital Universitario Virgen del Rocío Seville Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Clinico Universitario de Valladolid Valladolid Spain

More Fundación EPIC trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06321757 on ClinicalTrials.gov ↗ ← All trials in Spain