Status:
NOT_YET_RECRUITING
REgistry of Paclitaxel Coated Drug Eluting Balloon in All Comers PaTients
Lead Sponsor:
Craigavon Area Hospital
Conditions:
CAD - Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
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 :...
Detailed Description
Percutaneous coronary intervention (PCI) is a minimally invasive procedure treated as first line of treatment for symptomatic coronary artery disease (CAD). In 1977, Gruentzig performed the first ball...
Eligibility Criteria
Inclusion
- 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.
- Coronary angiographic inclusion criteria:
- ≥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)
- \*pre-dilation permitted with SC or NC balloon catheter, cutting/scoring balloon, rotational/orbital atherectomy, or laser
- Target vessel reference diameter between 2.0 and 4.5 mm.
Exclusion
- 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
- Allergy to imaging contrast media which cannot be adequately pre-medicated.
- Patient undergoing planned surgery within 3 months with the necessity to stop dual antiplatelet therapy (DAPT).
- Patient is pregnant or breast feeding.
- Patient has received a heart transplant.
- Patient is unwilling or unable to give follow-up until study completion.
- Patient is currently participating in another trial.
- Life expectancy \<1 year.
- Angiographic exclusion criteria:
- Target lesion in the left main coronary artery.
- Flow limiting target vessel thrombus
- Vessel dissection requiring bailout stenting.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06899555
Start Date
May 1 2025
End Date
May 1 2027
Last Update
March 28 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.