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RECRUITINGOBSERVATIONAL

Acotec DCB Post Market Clinical Follow-up

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form 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 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

AcoArt Orchid (0.035"), AcoArt Tulip (0.018") and AcoArt Litos (0.014") percutaneous transluminal angioplasty (PTA) paclitaxel drug coated balloon catheter manufactured by Acotec Scientific Co., Ltd.

All comers Post Market Clinical Follow-up to continue the surveillance of the Acotec Drug Coated PTA Catheter AcoArt Orchid, AcoArt Tulip and AcoArt Litos in lower limb treatment

Locations (7)

Halle
Halle, Saxony-Anhalt, Germany
Eilenburg
Eilenburg, Germany
Department of Angiology, University Hospital Leipzig,
Leipzig, Germany
Elblandklinikum Radebeul
Radebeul, Germany
Elblandklinikum Radebeul
Riesa, Germany
REGIOMED Klinikum Sonneberg
Sonneberg, Germany
KKH Torgau
Torgau, Germany