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NCT Number: NCT04393389

Acotec DCB Post Market Clinical Follow-up

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

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Halle, Saxony-Anhalt, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Primary efficacy endpoint - non-CLI group

    Time frame: 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).

  2. Primary efficacy endpoint -CLI group

    Time frame: 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.

  3. Primary safety endpoint- non-CLI group

    Time frame: 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.

  4. Primary safety endpoint- CLI group

    Time frame: 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 outcomes

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

    Time frame: 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

  2. Rate of Target vessel revascularization (TVR)

    Time frame: 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

  3. Rate of Target limb revascularization

    Time frame: 6 months,12 months,24 months, 36months,48 months,60 months

    Target limb revascularization at 6, 12, 24, 36, 48, 60 months post-procedure

  4. Rate of CD-TLR

    Time frame: 6 months,12 months,24 months, 36months,48 months,60 months

    CD-TLR at 6, 24, 36, 48, 60 months post-procedure

  5. Rate of All-cause mortality

    Time frame: 6 months,12 months,24 months, 36months,48 months,60months

    All-cause mortality at 6, 12, 24, 36, 48, 60 months post procedure

  6. Rate of Device- or procedure-related death

    Time frame: 30 days, 6 months

    Device- or procedure-related death at 30 days and 6 months

  7. Rate of Major amputation

    Time frame: 6 months,12 months,24 months, 36months,48 months,60 months

    Major amputation at 6, 12, 24, 36, 48, 60 months post procedure

  8. Rate of Technical success

    Time frame: 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.

  9. Rate of Procedural success

    Time frame: 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

  10. Change in Rutherford clinical category (target limb)

    Time frame: 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

  11. Rate of primary sustained clinical improvement

    Time frame: 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.

  12. Rate of secondary sustained clinical improvement

    Time frame: 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

  13. Rate of (Major) Amputation-free survival - CLI group

    Time frame: 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

  14. Rate of Minor amputation - CLI group

    Time frame: 6 months,12 months,24 months, 36months,48 months,60 months

    Minor amputation at 6, 12, 24, 36, 48, 60 months post-procedure

  15. Rate of Wound healing - CLI group

    Time frame: 60 months

    healed or not; if not, improving, stagnant,worsening

  16. New or recurrent wound of the target limb - CLI group

    Time frame: 60 months

    New or recurrent wound of the target limb

Study contacts

Contact information is provided by the study sponsor or research team.

Schmidt Andrej

CONTACT

[email protected]

+49-341-97 ext. 18770

Sponsors and collaborators

Lead sponsor

Acotec Scientific Co., Ltd

Industry

Registry information

Official study title

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

Acronym: FLOWER

Important dates

Study start
2020
Primary completion
2025
Study completion
2027
First posted
May 19, 2020
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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