REgistry of Paclitaxel Coated Drug Eluting Balloon in All Comers PaTients
ConditionCAD - Coronary Artery Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCraigavon Area Hospital
About this trial
A post marketing, observational , multi centre, prospective registry to assess safety and performance of the Drug Eluting Balloon in patients undergoing percutaneous coronary intervention.
Rational : Although DEBs are generally considered safe, there remain many unanswered questions about DEB technology in a real-world population and only limited trial data from geographically or clinically diverse patient subgroups. To address some of the clinical and translational gaps in knowledge we thus plan a clinical registry to assess safety and performance of a novel design of a drug eluting
A real-world, all-comers coronary artery disease (CAD) population undergoing percutaneous coronary intervention (PCI) and suitable for treatment with a Paclitaxel Coated Coronary Balloon Dilatation Catheter.
Study Population - 500 Patients
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Patients with symptomatic coronary artery disease (including those with acute coronary syndromes or Chronic Coronary Syndromes) with either symptoms and/or ischaemia.
The patient must be able to understand and provide informed consent and comply with all study procedures.
≥70% target lesion stenosis in LAD, LCX or RCA (or branches) which after successful pre-dilatation* has a residual stenosis ≤ 30% and no dissection of Type C or greater than (NHLBI guidelines)
Disqualifiers
Left ventricular ejection fraction (LVEF) ≤ 30%
Acute ST elevation MI (STEMI)
Cardiogenic shock within 2 days prior to the index PCI.
Known contraindication or hypersensitivity to paclitaxel, and/or to any anti-thrombotic and anti-platelet class of drugs
Trial population
A real-world, all-comers coronary artery disease (CAD) population undergoing percutaneous coronary intervention (PCI) and suitable for treatment with a Paclitaxel Coated Coronary Balloon Dilatation Catheter.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: Single Arm, 500 Patients
Trial outcomes
Primary outcomes
1
Target Lesion failure
Target Lesion failure through 12-months \[composite of cardiac death, target vessel myocardial infarction (MI) and ischaemia-driven target lesion revascularization (TLR)\]
Time frame
12 MonthSecondary outcomes
1
Major Adverse Cardiac Event (MACE)
Major Adverse Cardiac Event (MACE) \[Time Frame: through 12 Months\] - Composite of all cause death, any MI, any revascularization Device success \[Time Frame: During index procedure\] - Defined as the ability of the study device to be delivered, dilated and retrieved from the target lesion. Procedural success \[Time Frame: From Index procedure till discharge\] - Defined as technical and angiographic success in the absence of Major Adverse Cardiac Events (MACE) during hospitalization.
Time frame
MACE at 1 year; Procedural & Device Success at BaselineLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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