Coronary Artery DiseasePARISNCT06321757
PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients
An observational study of Coronary Artery Disease, run by Fundación EPIC at 19 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Percutaneous Coronary Intervention with DCB and DAPT
- Type of treatment
- Medical device
- How many people
- 501 participants
- Where
- 19 sitesin 3 countries
- Study dates
- 26 Feb 2024to 30 Dec 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: drug-coated ballon therapy in real-world patients with small native vessel coronary artery disease
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
19 sites in 3 countries.
19 sites in 3 countries
Spain15 sites
Hospital General Universitario de Albacete
Albacete, 02008
Hospital General Universitario Dr. Balmis
Alicante, 03010
Hospital Universitario de Cruces
Barakaldo, 49803
University Hospital HM Montepríncipe
Boadilla del Monte, 28660
Hospital General Universitario de Ciudad Real
Ciudad Real, 13005
Hospital Universitario Clinico San Cecilio
Granada, 18016
Hospital Universitario Juan Ramon Jimenez
Huelva, 21005
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, 08907
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, 35010
Hospital Universitario de Leon
León, 24071
Hospital Universitario de La Princesa
Madrid, 28006
Hospital Universitario de Canarias
San Cristóbal de La Laguna
Hospital Universitario Virgen del Rocío
Seville, 41013
Hospital Universitario Y Politecnico La Fe
Valencia, 46026
Hospital Clinico Universitario de Valladolid
Valladolid, 47003
Italy2 sites
Clinica Mediterranea
Naples, 08122
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Palermo, 90146
About this study
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.
Read the detailed description
Post-market, prospective, multicenter, non-intervention study, to demonstrate the effectiveness of drug-coated ballon 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 PCI with DCB will be performed in patients with native vessel coronary artery disease based on the criterion of the treating physician. The angiographic study will be analyzed in a core lab (icicorelab) blinded to the procedural outcomes and the patients' follow-up.
As per clinical practice, 1-year clinical follow-up of all the patients will be conducted with a first assessment at 30 days, a second assessment at 6 months, and one final assessment at 12 months.
Should the patient have an elevated bleeding risk -defined as concomitant therapy with oral anticoagulation or a PRECISE-DAPT score ≥ 25- patients will be included in a high-bleeding risk substudy. The antiplatelet therapy regime will be administered according to the local investigator and the treating medical team.
- Conditions
- Coronary Artery Disease
- Being tested
- Percutaneous Coronary Intervention with DCB and DAPT
- Keywords
- drug-coated balloon, paclitaxel, small native vessel coronary artery disease, coronary stenoses
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary Intervention with DCB and DAPTDevice
- Patients with PCI (DCB) + standard DAPT standard dual antiplatelet therapy (DAPT)
- Patients with PCI (DCB) + short DAPT
| Study group | Role | What they receive |
|---|---|---|
| Patients with small native vessel coronary artery disease | - Patients with small native vessel coronary artery disease y/or patients with High Bleeding Risk Receives: Device: Percutaneous Coronary Intervention with DCB and DAPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of DCB therapy
Incidence of MACE, which is a composite endpoint including cardiac mortality, myocardial infarction, and new revascularization of the target lesion
Measured: 1 year
Secondary outcomes (8)
Cardiac death
Incidence of Cardiac death
Measured: 1 year
All-cause mortality
Incidence of All-cause mortality
Measured: 1 year
Target vessel myocardial infarction
Incidence of Target vessel myocardial infarction
Measured: 1 year
New target lesion revascularization (TLR)
Incidence of New target lesion revascularization (TLR)
Measured: 1 year
Target vessel failure (TVF)
Incidence of Target vessel failure (TVF)
Measured: 1 year
Major bleeding
Bleeding defined as BARC (Bleeding Academic Research Consortium) criteria 2,3 or 5
Measured: 1 year
Minor bleeding
Anemia, defined as Hb<12g/dL for women and <13g/dL for men
Measured: 1 year
1-year MACE indicende (cardiac mortality, myocardial infarction, and new revascularization of the target lesion) in high-bleeding risk patients treated with a short dual antiplatelet treatment (7 days)
safety analysis of short DAP (dual antiplatelet therapy) in terms of thrombotic risk after PCI
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start26 Feb 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 501 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Fundación EPIC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321757
- Sponsor's protocol ID
- EPIC30-PARIS
- Acronym
- PARIS
- Status last verified
- Jul 2026
- First submitted
- 16 Feb 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gruntzig A. Transluminal dilatation of coronary-artery stenosis. Lancet. 1978 Feb 4;1(8058):263. doi: 10.1016/s0140-6736(78)90500-7. No abstract available.
PubMed 74678Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med. 1987 Mar 19;316(12):701-6. doi: 10.1056/NEJM198703193161201.
PubMed 2950322Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.
PubMed 12050336Kirtane AJ, Gupta A, Iyengar S, Moses JW, Leon MB, Applegate R, Brodie B, Hannan E, Harjai K, Jensen LO, Park SJ, Perry R, Racz M, Saia F, Tu JV, Waksman R, Lansky AJ, Mehran R, Stone GW. Safety and efficacy of drug-eluting and bare metal stents: comprehensive meta-analysis of randomized trials and observational studies. Circulation. 2009 Jun 30;119(25):3198-206. doi: 10.1161/CIRCULATIONAHA.108.826479. Epub 2009 Jun 15.
PubMed 19528338Kleber FX, Schulz A, Waliszewski M, Hauschild T, Bohm M, Dietz U, Cremers B, Scheller B, Clever YP. Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty. Clin Res Cardiol. 2015 Mar;104(3):217-25. doi: 10.1007/s00392-014-0775-2. Epub 2014 Oct 28.
PubMed 25349065
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients
- ClinicalTrials.gov ID
- NCT06321757
- Acronym / sponsor ID
- PARIS / EPIC30-PARIS
- Conditions
- Coronary Artery Disease
- Keywords
- drug-coated balloon, paclitaxel, small native vessel coronary artery disease, coronary stenoses
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Fundación EPICUniversity, hospital or other
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Post-market, prospective, multicenter, non-intervention study, to demonstrate the effectiveness of drug-coated ballon 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 PCI with DCB will be performed in patients with native vessel coronary artery disease based on the criterion of the treating physician. The angiographic study will be analyzed in a core lab (icicorelab) blinded to the procedural outcomes and the patients' follow-up.
As per clinical practice, 1-year clinical follow-up of all the patients will be conducted with a first assessment at 30 days, a second assessment at 6 months, and one final assessment at 12 months.
Should the patient have an elevated bleeding risk -defined as concomitant therapy with oral anticoagulation or a PRECISE-DAPT score ≥ 25- patients will be included in a high-bleeding risk substudy. The antiplatelet therapy regime will be administered according to the local investigator and the treating medical team.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with small native vessel coronary artery disease | – | Device: Percutaneous Coronary Intervention with DCB and DAPT- Patients with small native vessel coronary artery disease y/or patients with High Bleeding Risk |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- drug-coated ballon therapy in real-world patients with small native vessel coronary artery disease
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Coronary Intervention with DCB and DAPT* Patients with PCI (DCB) + standard DAPT standard dual antiplatelet therapy (DAPT) * Patients with PCI (DCB) + short DAPT | Device | Patients with small native vessel coronary artery disease |
Primary outcome
Effectiveness of DCB therapy
Time frame: 1 year
Incidence of MACE, which is a composite endpoint including cardiac mortality, myocardial infarction, and new revascularization of the target lesion
8 secondary outcomes
Cardiac death
Time frame: 1 year
All-cause mortality
Time frame: 1 year
Target vessel myocardial infarction
Time frame: 1 year
New target lesion revascularization (TLR)
Time frame: 1 year
Target vessel failure (TVF)
Time frame: 1 year
Major bleeding
Time frame: 1 year
Minor bleeding
Time frame: 1 year
1-year MACE indicende (cardiac mortality, myocardial infarction, and new revascularization of the target lesion) in high-bleeding risk patients treated with a short dual antiplatelet treatment (7 days)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Background: PubMed 74678Gruntzig A. Transluminal dilatation of coronary-artery stenosis. Lancet. 1978 Feb 4;1(8058):263. doi: 10.1016/s0140-6736(78)90500-7. No abstract available.
- Background: PubMed 2950322Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med. 1987 Mar 19;316(12):701-6. doi: 10.1056/NEJM198703193161201.
- Background: PubMed 12050336Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.
- Background: PubMed 19528338Kirtane AJ, Gupta A, Iyengar S, Moses JW, Leon MB, Applegate R, Brodie B, Hannan E, Harjai K, Jensen LO, Park SJ, Perry R, Racz M, Saia F, Tu JV, Waksman R, Lansky AJ, Mehran R, Stone GW. Safety and efficacy of drug-eluting and bare metal stents: comprehensive meta-analysis of randomized trials and observational studies. Circulation. 2009 Jun 30;119(25):3198-206. doi: 10.1161/CIRCULATIONAHA.108.826479. Epub 2009 Jun 15.
- Background: PubMed 25349065Kleber FX, Schulz A, Waliszewski M, Hauschild T, Bohm M, Dietz U, Cremers B, Scheller B, Clever YP. Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty. Clin Res Cardiol. 2015 Mar;104(3):217-25. doi: 10.1007/s00392-014-0775-2. Epub 2014 Oct 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Fundación EPIC at 19 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Spain, Italy, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of DCB therapy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06321757, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.