Actively Recruiting
PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients
Led by Fundación EPIC · Updated on 2026-04-17
501
Participants Needed
18
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with PCI using drug-coated balloons on native arteries less than 3 mm in diameter
- Indication for PCI due to acute coronary syndrome, chronic coronary syndrome, or silent angina
- If lesion preparation was needed, no residual lesion with diameter stenosis over 30% or flow-limiting coronary dissections
- All prior antithrombotic therapies allowed and may be adjusted after procedure
- Ability to understand and sign informed consent
- High-bleeding risk patients with PRECISE-DAPT score 25 or higher or indication for oral anticoagulation may be included if exclusion criteria are not met
You will not qualify if you...
- Lesions on vessels larger than 3 mm in the same coronary territory
- PCI on in-stent restenosis lesions
- PCI on culprit lesions of acute coronary syndrome with ST segment elevation
- Life expectancy less than 12 months
- Pregnancy
- Participation in other clinical trials
- Inability to provide written informed consent
- For high-bleeding risk subgroup: history of stent thrombosis or need for dual antiplatelet therapy for other reasons
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 18 locations
1
Clinica Mediterranea
Naples, Italy, 08122
Actively Recruiting
2
Ulslo-H.Santa Cruz
Carnaxide, Portugal
Actively Recruiting
3
ULS Santa Maria
Lisbon, Portugal
Actively Recruiting
4
Hospital General Universitario de Albacete
Albacete, Spain, 02008
Actively Recruiting
5
Hospital General Universitario Dr. Balmis
Alicante, Spain, 03010
Actively Recruiting
6
Hospital Universitario de Cruces
Barakaldo, Spain, 49803
Actively Recruiting
7
University Hospital HM Montepríncipe
Boadilla del Monte, Spain, 28660
Actively Recruiting
8
Hospital General Universitario de Ciudad Real
Ciudad Real, Spain, 13005
Actively Recruiting
9
Hospital Universitario Clinico San Cecilio
Granada, Spain, 18016
Actively Recruiting
10
Hospital Universitario Juan Ramon Jimenez
Huelva, Spain, 21005
Actively Recruiting
11
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain, 08907
Actively Recruiting
12
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, Spain, 35010
Actively Recruiting
13
Hospital Universitario de Leon
León, Spain, 24071
Actively Recruiting
14
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Actively Recruiting
15
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Spain
Actively Recruiting
16
Hospital Universitario Virgen del Rocío
Seville, Spain, 41013
Actively Recruiting
17
Hospital Universitario Y Politecnico La Fe
Valencia, Spain, 46026
Actively Recruiting
18
Hospital Clinico Universitario de Valladolid
Valladolid, Spain, 47003
Actively Recruiting
Research Team
I
IGNACIO J AMAT SANTOS, MD, PhD
CONTACT
F
FUNDACION EPIC
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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