No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
3,000 (estimated)
Sponsor
Acotec Scientific Co., Ltd · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
* …
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.
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