Peripheral Artery DiseaseFLOWERNCT04393389
Acotec DCB Post Market Clinical Follow-up
An observational study of Peripheral Artery Disease, run by Acotec Scientific Co., Ltd at 7 sites in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- 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.
- Type of treatment
- Medical device
- How many people
- 3,000 participants
- Where
- 7 sitesGermany
- Study dates
- 4 Jun 2020to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with symptomatic arterial disease undergoing endovascular lower limb revascularization per the institution's standard practice.
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Germany7 sites, 7 recruiting
- Recruiting
Eilenburg
Eilenburg
Johannes Schuster
- Recruiting
Halle
Halle, Saxony-Anhalt
Corneliu-Gheorge Popescu
- Recruiting
Department of Angiology, University Hospital Leipzig,
Leipzig
Andrej Schmidt
- Recruiting
Elblandklinikum Radebeul
Radebeul
Torsten Fuss
- Recruiting
Elblandklinikum Radebeul
Riesa
Torsten Fuss
- Recruiting
REGIOMED Klinikum Sonneberg
Sonneberg
Marcus Thieme
- Recruiting
KKH Torgau
Torgau
Lars Maiwald
About this study
Official 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
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
Read the 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.
- Conditions
- Peripheral Artery Disease
- Being tested
- 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.
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| non-CLI group | Rutherford Clinical Category (RCC) 2-3 Receives: 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 12 Months
Secondary outcomes (16)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days, 6 months
Rate of Major amputation
Major amputation at 6, 12, 24, 36, 48, 60 months post procedure
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 60 months
New or recurrent wound of the target limb - CLI group
New or recurrent wound of the target limb
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start4 Jun 2020
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acotec Scientific Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Schmidt Andrej, Principal investigator, Department of Angiology, University Hospital Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393389
- Sponsor's protocol ID
- Acotec-07
- Acronym
- FLOWER
- Status last verified
- Jul 2024
- First submitted
- 13 May 2020
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04393389
- Acronym / sponsor ID
- FLOWER / Acotec-07
- Conditions
- Peripheral Artery Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Acotec Scientific Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-CLI group | – | 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.Rutherford Clinical Category (RCC) 2-3 |
| CLI group | – | 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.critical limb ischemia，Rutherford Clinical Category (RCC) 4-6 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with symptomatic arterial disease undergoing endovascular lower limb revascularization per the institution's standard practice.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | CLI group, non-CLI group |
Primary outcome
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).
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.
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.
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
16 secondary outcomes
Rate of Any TLR (including clinically-driven and incidental TLR)
Time frame: 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
Rate of Target limb revascularization
Time frame: 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
Rate of All-cause mortality
Time frame: 6 months,12 months,24 months, 36months,48 months,60months
Rate of Device- or procedure-related death
Time frame: 30 days, 6 months
Rate of Major amputation
Time frame: 6 months,12 months,24 months, 36months,48 months,60 months
Rate of Technical success
Time frame: Post procedure
Rate of Procedural success
Time frame: Post procedure
Change in Rutherford clinical category (target limb)
Time frame: 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
Rate of secondary sustained clinical improvement
Time frame: 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
Rate of Minor amputation - CLI group
Time frame: 6 months,12 months,24 months, 36months,48 months,60 months
Rate of Wound healing - CLI group
Time frame: 60 months
New or recurrent wound of the target limb - CLI group
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Schmidt Andrej principal investigator
Department of Angiology, University Hospital Leipzig
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease, run by Acotec Scientific Co., Ltd at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Schmidt Andrej (+49-341-97 ext. 18770, Andrej.Schmidt@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy endpoint - non-CLI group (time frame: 12 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.