Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3000 participants
OBSERVATIONAL
2020-06-04
2027-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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non-CLI group
Rutherford Clinical Category (RCC) 2-3
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
CLI group
critical limb ischemia，Rutherford Clinical Category (RCC) 4-6
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Acotec Scientific Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Schmidt Andrej
Role: PRINCIPAL_INVESTIGATOR
Department of Angiology, University Hospital Leipzig
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Corneliu-Gheorge Popescu
Role: primary
Johannes Schuster
Role: primary
Andrej Schmidt
Role: primary
Torsten Fuss
Role: primary
Torsten Fuss
Role: primary
Marcus Thieme
Role: primary
Lars Maiwald
Role: primary
Other Identifiers
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Acotec-07
Identifier Type: -
Identifier Source: org_study_id
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