Acotec DCB Post Market Clinical Follow-up

NCT04393389 | Recruiting

• 1 other identifier: Acotec-07
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 7

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

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (4)

• 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).

  12 Months

• 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.

  6 Months

• 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.

  30 days

• 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

  12 Months

Secondary Outcomes (16)

• Rate of Any TLR (including clinically-driven and incidental TLR)

  6 months,12 months,24 months, 36months,48 months,60 months

• Rate of Target vessel revascularization (TVR)

  6 months,12 months,24 months, 36months,48 months,60 months

• Rate of Target limb revascularization

  6 months,12 months,24 months, 36months,48 months,60 months

• Rate of CD-TLR

  6 months,12 months,24 months, 36months,48 months,60 months

• Rate of All-cause mortality

  6 months,12 months,24 months, 36months,48 months,60months

Study Arms (2)

non-CLI group

Rutherford Clinical Category (RCC) 2-3

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.

CLI group

critical limb ischemia，Rutherford Clinical Category (RCC) 4-6

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.

Interventions

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. DEVICE

All 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

CLI group; non-CLI group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with symptomatic arterial disease undergoing endovascular lower limb revascularization per the institution's standard practice.

You may qualify if:

• \. Patient is ≥ 18 years old at the time of consent.
• \. 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.
• \. 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.
• \. 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.
• \. Rutherford Classification Category 2-6 Subjects with Rutherford Category 2 have gone through a conservative therapy without success.
• \. Inflow lesion treated prior to target lesion treatment

You may not qualify if:

• \. Rutherford Classification Category 0, 1
• \. Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints
• \. Inability to tolerate required antithrombotic or antiplatelet therapies.
• \. Non-dilatable severely calcified lesion.
• \. Known hypersensitivity/allergy to components of the investigational device
• \. Un-treated acute or subacute thrombus in the target lesion.
• \. Life expectancy \< 1 year.
• \. Pregnancy or female patient with child bearing potential not taking adequate contraceptives or currently lactating.
• \. Other comorbidities, which in the opinion of the investigator limit longevity or likelihood of compliance with protocol follow up.
• \. Myocardial infarction or stroke within 30 days prior to index procedure.

Sponsors & Collaborators

• Acotec Scientific Co., Ltd: lead

Study Sites (7)

Halle

Halle, Saxony-Anhalt, Germany

RECRUITING

Eilenburg

Eilenburg, Germany

RECRUITING

Department of Angiology, University Hospital Leipzig,

Leipzig, Germany

RECRUITING

Elblandklinikum Radebeul

Radebeul, Germany

RECRUITING

Elblandklinikum Radebeul

Riesa, Germany

RECRUITING

REGIOMED Klinikum Sonneberg

Sonneberg, Germany

RECRUITING

KKH Torgau

Torgau, Germany

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Schmidt Andrej

  Department of Angiology, University Hospital Leipzig

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Schmidt Andrej

CONTACT

+49-341-97; Andrej.Schmidt@medizin.uni-leipzig.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 19, 2020
• Study Start: June 4, 2020
• Primary Completion: December 1, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

DE (7)