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
Qualifiers
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 design
Treatments tested in this trial
- Not listed
Trial groups
500 Participants
are grouped into 1 trial groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov