Acotec DCB Post Market Clinical Follow-up

Recruiting

• Conditions: Peripheral Artery Disease
• Interventions: Device: 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.

• Registration Number: NCT04393389
• Lead Sponsor: Acotec Scientific Co., Ltd

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

Detailed Description

To prospectively collect and assess safety and efficacy data on the AcoArt drug-coated PTA balloon catheters carrying the CE Mark per current Instructions for Use in a real-world cohort of patients with symptomatic arterial disease undergoing endovascular lower limb revascularization per the institution's standard practice.

Study Timeline

• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-14
• Study First Posted: 2020-05-19
• Study Start: 2020-06-04
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01
• Primary Completion: 2025-12-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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) 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-CLI group	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.	Rutherford Clinical Category (RCC) 2-3
CLI group	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.	critical limb ischemia，Rutherford Clinical Category (RCC) 4-6

Primary Outcome Measures

Name	Time	Method
Primary efficacy endpoint -CLI group	6 Months	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.
Primary safety endpoint- non-CLI group	30 days	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.
Primary efficacy endpoint - non-CLI group	12 Months	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).
Primary safety endpoint- CLI group	12 Months	A composite of freedom from device- and procedure-related mortality, freedom from major target limb amputation and TLR within 12 months post-index procedure

Secondary Outcome Measures

Name	Time	Method
Rate of (Major) Amputation-free survival - CLI group	6 months,12 months,24 months, 36months,48 months,60 months	(Major) Amputation-free survival at 6, 12, 24, 36, 48, 60 months post-procedure
Rate of Device- or procedure-related death	30 days, 6 months	Device- or procedure-related death at 30 days and 6 months
Rate of CD-TLR	6 months,12 months,24 months, 36months,48 months,60 months	CD-TLR at 6, 24, 36, 48, 60 months post-procedure
Rate of All-cause mortality	6 months,12 months,24 months, 36months,48 months,60months	All-cause mortality at 6, 12, 24, 36, 48, 60 months post procedure
Rate of Major amputation	6 months,12 months,24 months, 36months,48 months,60 months	Major amputation at 6, 12, 24, 36, 48, 60 months post procedure
Rate of Wound healing - CLI group	60 months	healed or not; if not, improving, stagnant,worsening
Rate of Target vessel revascularization (TVR)	6 months,12 months,24 months, 36months,48 months,60 months	Target vessel revascularization (TVR) at 6, 12, 24, 36, 48, 60 months post-procedure
Rate of Target limb revascularization	6 months,12 months,24 months, 36months,48 months,60 months	Target limb revascularization at 6, 12, 24, 36, 48, 60 months post-procedure
Rate of Any TLR (including clinically-driven and incidental TLR)	6 months,12 months,24 months, 36months,48 months,60 months	Any TLR (including clinically-driven and incidental TLR) at 6,12, 24, 36, 48, 60 months post-procedure
Rate of Procedural success	Post procedure	Procedural success defined as technical success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or CD-TLR) prior to discharge
Rate of primary sustained clinical improvement	6 months,12 months,24 months, 36months,48 months,60 months	Primary sustained clinical improvement, defined as improvement in Rutherford classification by one or more categories compared with baseline, without TLR.
Rate of Technical success	Post procedure	Technical success defined as final in-lesion residual diameter stenosis ≤50% by angiographic visual estimate at the end of the index procedure without device malfunction.
Change in Rutherford clinical category (target limb)	6 months,12 months,24 months, 36months,48 months,60 months	Changes in Rutherford clinical category (target limb) at 6, 12, 24, 36, 48, 60 months post-procedure compared to baseline
Rate of secondary sustained clinical improvement	6 months,12 months,24 months, 36months,48 months,60 months	Secondary sustained clinical improvement, defined as improvement in Rutherford classification by one or more categories compared with baseline, including patients with TLR
Rate of Minor amputation - CLI group	6 months,12 months,24 months, 36months,48 months,60 months	Minor amputation at 6, 12, 24, 36, 48, 60 months post-procedure
New or recurrent wound of the target limb - CLI group	60 months	New or recurrent wound of the target limb

Trial Locations

Locations (6)

Halle; 🇩🇪 Halle, Saxony-Anhalt, Germany

Eilenburg; 🇩🇪 Eilenburg, Germany

Department of Angiology, University Hospital Leipzig,; 🇩🇪 Leipzig, Germany

Elblandklinikum Radebeul; 🇩🇪 Riesa, Germany

KKH Torgau; 🇩🇪 Torgau, Germany

REGIOMED Klinikum Sonneberg; 🇩🇪 Sonneberg, Germany