NCT04393389 Acotec DCB Post Market Clinical Follow-up
| NCT ID | NCT04393389 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Acotec Scientific Co., Ltd |
| Condition | Peripheral Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2020-06-04 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2020-06-04 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
All-comers, prospective, multi-center, single-arm, non-interventional post market clinical follow-up (PMCF) Cohort 1 - Claudicants: Rutherford Clinical Category (RCC) 2-3 Cohort 2 - Critical Limb Ischemia: Rutherford Clinical Category (RCC) 4-6
Eligibility 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.
Contact & Investigator
Schmidt Andrej
PRINCIPAL INVESTIGATOR
Department of Angiology, University Hospital Leipzig
Frequently Asked Questions
Who can join the NCT04393389 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04393389 currently recruiting?
Yes, NCT04393389 is actively recruiting participants. Contact the research team at Andrej.Schmidt@medizin.uni-leipzig.de for enrollment information.
Where is the NCT04393389 trial being conducted?
This trial is being conducted at Halle, Germany, Eilenburg, Germany, Leipzig, Germany, Radebeul, Germany and 3 additional locations.
Who is sponsoring the NCT04393389 clinical trial?
NCT04393389 is sponsored by Acotec Scientific Co., Ltd. The principal investigator is Schmidt Andrej at Department of Angiology, University Hospital Leipzig. The trial plans to enroll 3,000 participants.