Acotec DCB Post Market Clinical Follow-up
ConditionPeripheral Artery Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcotec Scientific Co., Ltd
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 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.
Treatment groups
3,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov