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)
Effectiveness of DCB therapy — 1 year Incidence of MACE, which is a composite endpoint including cardiac mortality, myocardial infarction, and new revascularization of the target lesion
Trial sites (19)
Facility
City
Region
Status
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
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.