Acotec DCB Post Market Clinical Follow-up
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Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Acotec Scientific Co., Ltd
- Trial code
- NCT04393389
- Record updated
- 1 August 2024
- Original description
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) 4-6Read full original descriptionShow less
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
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
Inclusion: 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: 3. Inability to tolerate required antithrombotic or antiplatelet therapies; 5. Known hypersensitivity/allergy to components of the investigational device; 10. Myocardial infarction or stroke within 30 days prior to index procedure; 1. Rutherford Classification Category 0, 1; 2. Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints; 4. Non-dilatable severely calcified lesion; 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.