Follow-up on the use of drug-coated balloons for treating peripheral artery disease
All Comers Post Market Clinical Follow-up to Continue the Surveillance of the Acotec Drug Coated PTA Catheter Orchid, Tulip and Litos in Lower Limb Treatment
This study is trying to see how well AcoArt drug-coated balloons work and how safe they are for people with peripheral artery disease who have either leg pain or severe circulation problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Acotec Scientific Co., Ltd Industry-sponsored |
| Locations | 7 sites (Halle, Saxony-Anhalt and 6 other locations) |
| Trial ID | NCT04393389 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect and evaluate safety and efficacy data on AcoArt drug-coated balloon catheters used in patients with symptomatic peripheral artery disease. It includes two cohorts: one for patients with claudication and another for those with critical limb ischemia. The study will assess patients undergoing endovascular lower limb revascularization in a real-world setting, following standard practices at participating institutions. The data collected will help understand the performance of these devices in treating significant arterial lesions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with significant arterial stenosis or occlusions suitable for angioplasty.
Not a fit: Patients with Rutherford Classification Categories 0 or 1, or those already enrolled in other investigational studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of drug-coated balloons in improving outcomes for patients with peripheral artery disease.
How similar studies have performed: Other studies have shown promising results with similar drug-coated balloon approaches, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Patient is ≥ 18 years old at the time of consent. * 2\. Significant stenosis (≥70%) or occlusions of de-novo or restenotic lesion(s) located in iliac, superficial femoral, popliteal and/or infra-popliteal arteries suitable for angioplasty per operator visual assessment. * 3\. Lesion(s) can be treated with available AcoArt Orchid (0.035"), AcoArt Tulip (0.018") and AcoArt Litos (0.014") DCB device per current IFU. * 4\. Subject has provided written informed consent prior to participation in the PMCF, understands the purpose of this PMCF and agrees to comply with all protocol-specified examinations and follow-up appointments. * 5\. Rutherford Classification Category 2-6 Subjects with Rutherford Category 2 have gone through a conservative therapy without success. * 6\. Inflow lesion treated prior to target lesion treatment Exclusion Criteria: * 1\. Rutherford Classification Category 0, 1 * 2\. Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints * 3\. Inability to tolerate required antithrombotic or antiplatelet therapies. * 4\. Non-dilatable severely calcified lesion. * 5\. Known hypersensitivity/allergy to components of the investigational device * 6\. Un-treated acute or subacute thrombus in the target lesion. * 7\. Life expectancy \< 1 year. * 8\. Pregnancy or female patient with child bearing potential not taking adequate contraceptives or currently lactating. * 9\. Other comorbidities, which in the opinion of the investigator limit longevity or likelihood of compliance with protocol follow up. * 10\. Myocardial infarction or stroke within 30 days prior to index procedure.
Where this trial is running
Halle, Saxony-Anhalt and 6 other locations
- Halle — Halle, Saxony-Anhalt, Germany (Recruiting)
- Eilenburg — Eilenburg, Germany (Recruiting)
- Department of Angiology, University Hospital Leipzig, — Leipzig, Germany (Recruiting)
- Elblandklinikum Radebeul — Radebeul, Germany (Recruiting)
- Elblandklinikum Radebeul — Riesa, Germany (Recruiting)
- REGIOMED Klinikum Sonneberg — Sonneberg, Germany (Recruiting)
- KKH Torgau — Torgau, Germany (Recruiting)
Study contacts
- Principal investigator: Schmidt Andrej — Department of Angiology, University Hospital Leipzig
- Study coordinator: Schmidt Andrej
- Email: Andrej.Schmidt@medizin.uni-leipzig.de
- Phone: +49-341-97
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.