Comparing the effects of two drug-eluting balloons for treating peripheral artery disease
Scientific Proposal to Substantiate Vascular Effects Through Sirolimus vs. Paclitaxel DCB Implantation
This study is testing two different drug-eluting balloons to see which one helps improve blood flow and artery health in people with peripheral artery disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Essen Academic / other |
| Locations | 1 site (Essen, NRW) |
| Trial ID | NCT05450042 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the vascular effects of two different drug-eluting balloons, SELUTION SLR and Paclitaxel, in patients with symptomatic peripheral artery disease (PAD). The study aims to assess improvements in local vascular function through measurements of flow-mediated dilation, arterial stiffness, and vascular strain analysis. Participants will undergo percutaneous transluminal angioplasty (PTA) with either device, and their outcomes will be compared to determine which balloon offers better vascular benefits. The trial includes patients aged 18 to 85 with specific inclusion criteria related to their vascular condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with chronic symptomatic lower limb ischemia due to peripheral artery disease.
Not a fit: Patients with bifurcational lesions, instent-restenosis, or recent thrombolysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved vascular function and reduced complications for patients with peripheral artery disease.
How similar studies have performed: Other studies have shown promising results with drug-eluting balloons in treating peripheral artery disease, suggesting this approach has potential.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Peripheral artery disease * Target lesions 3 cm distal to the CFA-bifurcation including SFA and PA lesions * Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2, 3, 4 and 5 * Planed peripheral intervention TASC A-D * Subject must be between 18 and 85 years old * Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12-month angiographic evaluation * Vessel diameter ≥4.0 mm and ≤7.0 mm * Willing to comply with the specified follow-up evaluation * Written informed consent prior to any study procedures * Pretreatment with an adequately sized balloon Exclusion Criteria: * Bifurcational lesions of the CFA and lesions including the first 3 cm of the SFA, due to technical aspects of FMD measurement * Instent-Restenosis * Thrombolysis within 72 hours prior to the index procedure * Aneurysm formations in the femoral artery or popliteal artery * Concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy * Unstable angina pectoris at the time of the enrollment * Recent myocardial infarction or stroke \< 30 days prior to the index procedure * Life expectancy less than 12 months
Where this trial is running
Essen, NRW
- University of Essen, Clinic of Cardiology and Angiology — Essen, Nrw, Germany (Recruiting)
Study contacts
- Principal investigator: Christos Rammos, Professor — University Hospital, Essen
- Study coordinator: Christos Rammos, Professor
- Email: christos.rammos@uk-essen.de
- Phone: 0201-723-84808
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.