REgistry of Paclitaxel Coated Drug Eluting Balloon in All Comers PaTients

NCT06899555 | Not Yet Recruiting DMC

• 1 other identifier: TL/PMS/DEB/2024-01
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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 : 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

Conditions

CAD - Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Target Lesion failure

  Target Lesion failure through 12-months \[composite of cardiac death, target vessel myocardial infarction (MI) and ischaemia-driven target lesion revascularization (TLR)\]

  12 Month

Secondary Outcomes (1)

• Major Adverse Cardiac Event (MACE)

  MACE at 1 year; Procedural & Device Success at Baseline

Study Arms (1)

Single Arm, 500 Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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)
• \*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.

You may not qualify if:

• 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.
• Target lesion in the left main coronary artery.
• Flow limiting target vessel thrombus
• Vessel dissection requiring bailout stenting.

Sponsors & Collaborators

• Craigavon Area Hospital: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Dr Ian Brian Alexander Menown, MD(QUB), MB BCh BAO(QUB), MRCP

CONTACT

+ 44 2838 334444; ian.menown@southerntrust.hscni.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Interventional Research, Craigavon

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 28, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share