Acotec DCB Post Market Clinical Follow-up

Peripheral Artery Disease Clinical Trial

— FLOWER  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04393389
• Other study ID #: Acotec-07
• Status: Recruiting
• Start date: June 4, 2020
• Est. completion date: March 1, 2027

Study information

• Verified date: June 2023
• Source: Acotec Scientific Co., Ltd
• Contact: Schmidt Andrej
• Phone: +49-341-97
• Email: Andrej.Schmidt[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: March 1, 2027
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

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

Locations

Country	Name	City	State
Germany	Eilenburg	Eilenburg
Germany	Halle	Halle	Saxony-Anhalt
Germany	Department of Angiology, University Hospital Leipzig,	Leipzig
Germany	Elblandklinikum Radebeul	Radebeul
Germany	Elblandklinikum Radebeul	Riesa
Germany	REGIOMED Klinikum Sonneberg	Sonneberg
Germany	KKH Torgau	Torgau

Sponsors (1)

Lead Sponsor	Collaborator
Acotec Scientific Co., Ltd

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rate of Device- or procedure-related death	Device- or procedure-related death at 30 days and 6 months	30 days, 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rate of Wound healing - CLI group	healed or not; if not, improving, stagnant,worsening	60 months
Secondary	New or recurrent wound of the target limb - CLI group	New or recurrent wound of the target limb	60 months