Acotec DCB Post Market Clinical Follow-up (FLOWER)

July 30, 2024 updated by: Acotec Scientific Co., Ltd

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
12 Months
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.
6 Months
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.
30 days
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
12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
6 months,12 months,24 months, 36months,48 months,60 months
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
6 months,12 months,24 months, 36months,48 months,60 months
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
6 months,12 months,24 months, 36months,48 months,60 months
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
6 months,12 months,24 months, 36months,48 months,60 months
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 months,12 months,24 months, 36months,48 months,60months
Rate of Device- or procedure-related death
Time Frame: 30 days, 6 months
Device- or procedure-related death at 30 days and 6 months
30 days, 6 months
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
6 months,12 months,24 months, 36months,48 months,60 months
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.
Post procedure
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
Post procedure
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
6 months,12 months,24 months, 36months,48 months,60 months
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.
6 months,12 months,24 months, 36months,48 months,60 months
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
6 months,12 months,24 months, 36months,48 months,60 months
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
6 months,12 months,24 months, 36months,48 months,60 months
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
6 months,12 months,24 months, 36months,48 months,60 months
Rate of Wound healing - CLI group
Time Frame: 60 months
healed or not; if not, improving, stagnant,worsening
60 months
New or recurrent wound of the target limb - CLI group
Time Frame: 60 months
New or recurrent wound of the target limb
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Acotec Scientific Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Schmidt Andrej, Department of Angiology, University Hospital Leipzig

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 4, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings