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
This trial does not accept healthy volunteersQualifiers
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 population
patients with symptomatic arterial disease undergoing endovascular lower limb revascularization per the institution's standard practice.
Trial design
Design model
Cohort
Time perspective
Prospective
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.
DeviceAll 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
Treatment groups
3,000 Participants
are divided into 2 treatment groupsGroup A: non-CLI group1 intervention
Group B: CLI group1 intervention
Trial outcomes
Primary outcomes
1
Primary efficacy endpoint - non-CLI group
Freedom from clinically-driven target lesion revascularization (CD-TLR) within 12 months after index procedure, which is defined as any re-intervention within the target lesion(s) due to recurrent clinical symptoms of PAD (increase of one Rutherford class or more) and/or drop of ankle-brachial index (≥20% or \>0.15 when compared with maximum early post-procedural level).
Time frame
12 Months2
Primary efficacy endpoint -CLI group
Freedom from clinically-driven TLR within 6 months after index procedure, which is defined as any re-intervention within the target lesion(s) due to delayed or worsening wound healing, new or recurrent wound, or worsening Rutherford class.
Time frame
6 Months3
Primary safety endpoint- non-CLI group
A composite of freedom from major adverse limb events and perioperative death (MALE-POD) through 30 days after index procedure. A major adverse limb event is defined as above-ankle amputation or major reintervention (ie, new bypass graft, major surgical graft revision such as a jump graft or an interposition graft, or thrombectomy/thrombolysis) of the treated limb.
Time frame
30 days4
Primary safety endpoint- CLI group
A composite of freedom from device- and procedure-related mortality, freedom from major target limb amputation and TLR within 12 months post-index procedure
Time frame
12 MonthsSecondary outcomes
1
Rate of Any TLR (including clinically-driven and incidental TLR)
Any TLR (including clinically-driven and incidental TLR) at 6,12, 24, 36, 48, 60 months post-procedure
Time frame
6 months,12 months,24 months, 36months,48 months,60 months2
Rate of Target vessel revascularization (TVR)
Target vessel revascularization (TVR) at 6, 12, 24, 36, 48, 60 months post-procedure
Time frame
6 months,12 months,24 months, 36months,48 months,60 months3
Rate of Target limb revascularization
Target limb revascularization at 6, 12, 24, 36, 48, 60 months post-procedure
Time frame
6 months,12 months,24 months, 36months,48 months,60 months4
Rate of CD-TLR
CD-TLR at 6, 24, 36, 48, 60 months post-procedure
Time frame
6 months,12 months,24 months, 36months,48 months,60 monthsSponsors and contacts
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Source ClinicalTrials.gov