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

Fundación EPIC

Status

Enrolling

Conditions

Coronary Artery Disease

Treatments

Device: Percutaneous Coronary Intervention with DCB and DAPT

Study type

Observational

Funder types

Other

Identifiers

NCT06321757

EPIC30-PARIS

Details and patient eligibility

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.

Full 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.

Enrollment

501 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.