Acotec DCB Post Market Clinical Follow-up (FLOWER)

All Comers Post Market Clinical Follow-up to Continue the Surveillance of the Acotec Drug Coated PTA Catheter Orchid, Tulip and Litos in Lower Limb Treatment

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

Study Overview

• Status: Recruiting
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: 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.

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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Schmidt Andrej; Phone Number: 18770 +49-341-97; Email: Andrej.Schmidt@medizin.uni-leipzig.de

Study Locations

• Germany
  • Eilenburg, Germany
    • Recruiting
    • Eilenburg
    • Contact: Johannes Schuster
  • Leipzig, Germany
    • Recruiting
    • Department of Angiology, University Hospital Leipzig,
    • Contact: Andrej Schmidt
  • Radebeul, Germany
    • Recruiting
    • Elblandklinikum Radebeul
    • Contact: Torsten Fuss
  • Riesa, Germany
    • Recruiting
    • Elblandklinikum Radebeul
    • Contact: Torsten Fuss
  • Sonneberg, Germany
    • Recruiting
    • REGIOMED Klinikum Sonneberg
    • Contact: Marcus Thieme
  • Torgau, Germany
    • Recruiting
    • KKH Torgau
    • Contact: Lars Maiwald
  • Saxony-Anhalt
    • Halle, Saxony-Anhalt, Germany
      • Recruiting
      • Halle
      • Contact: Corneliu-Gheorge Popescu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.; 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; 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.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months,12 months,24 months, 36months,48 months,60 months
Rate of Target vessel revascularization (TVR)	Target vessel revascularization (TVR) at 6, 12, 24, 36, 48, 60 months post-procedure	6 months,12 months,24 months, 36months,48 months,60 months
Rate of Target limb revascularization	Target limb revascularization at 6, 12, 24, 36, 48, 60 months post-procedure	6 months,12 months,24 months, 36months,48 months,60 months
Rate of CD-TLR	CD-TLR at 6, 24, 36, 48, 60 months post-procedure	6 months,12 months,24 months, 36months,48 months,60 months
Rate of All-cause mortality	All-cause mortality at 6, 12, 24, 36, 48, 60 months post procedure	6 months,12 months,24 months, 36months,48 months,60months
Rate of Device- or procedure-related death	Device- or procedure-related death at 30 days and 6 months	30 days, 6 months
Rate of Major amputation	Major amputation at 6, 12, 24, 36, 48, 60 months post procedure	6 months,12 months,24 months, 36months,48 months,60 months
Rate of Technical success	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.	Post procedure
Rate of Procedural success	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	Post procedure
Change in Rutherford clinical category (target limb)	Changes in Rutherford clinical category (target limb) at 6, 12, 24, 36, 48, 60 months post-procedure compared to baseline	6 months,12 months,24 months, 36months,48 months,60 months
Rate of primary sustained clinical improvement	Primary sustained clinical improvement, defined as improvement in Rutherford classification by one or more categories compared with baseline, without TLR.	6 months,12 months,24 months, 36months,48 months,60 months
Rate of secondary sustained clinical improvement	Secondary sustained clinical improvement, defined as improvement in Rutherford classification by one or more categories compared with baseline, including patients with TLR	6 months,12 months,24 months, 36months,48 months,60 months
Rate of (Major) Amputation-free survival - CLI group	(Major) Amputation-free survival at 6, 12, 24, 36, 48, 60 months post-procedure	6 months,12 months,24 months, 36months,48 months,60 months
Rate of Minor amputation - CLI group	Minor amputation at 6, 12, 24, 36, 48, 60 months post-procedure	6 months,12 months,24 months, 36months,48 months,60 months
Rate of Wound healing - CLI group	healed or not; if not, improving, stagnant,worsening	60 months
New or recurrent wound of the target limb - CLI group	New or recurrent wound of the target limb	60 months

Collaborators and Investigators

• Sponsor: Acotec Scientific Co., Ltd
• Investigators: Principal Investigator: Schmidt Andrej, Department of Angiology, University Hospital Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2020
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: Acotec-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No