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 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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) stu