Follow-up on the use of drug-coated balloons for treating peripheral artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.