NCT06899555Not yet recruiting
REgistry of Paclitaxel Coated Drug Eluting Balloon in All Comers PaTients
REgistry of Paclitaxel Coated Drug Eluting Balloon in All Comers PaTients (REPEAT Registry)
Source: ClinicalTrials.gov · Last updated 28 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 21 Mar 2025
- Start date
- May 2025
- Primary completion date
- May 2026
- Lead sponsor
- Craigavon Area Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT06899555
What you commit to
- Study type: Observational
- Planned participants: 500
- From May 2025 to the primary completion date, May 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Cardiogenic shock within 2 days prior to the index PCI.
- Patient undergoing planned surgery within 3 months with the necessity to stop dual antiplatelet therapy (DAPT).
- Patient has received a heart transplant.
Other illness
- Allergy to imaging contrast media which cannot be adequately pre-medicated.
Lab values
- Left ventricular ejection fraction (LVEF) ≤ 30%
- Known contraindication or hypersensitivity to paclitaxel, and/or to any anti-thrombotic and anti-platelet class of drugs
Other
- Acute ST elevation MI (STEMI)
- Patient is pregnant or breast feeding.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.