Acotec DCB Post Market Clinical Follow-up

NCT04393389 · tracked via the Priya Life Science Germany tracker

Sponsor

Acotec Scientific Co., Ltd

Phase

Observational

Started

2020-06-04

Last updated

2024-08-01

Condition(s) studied

Peripheral Artery Disease

Investigational drug(s) / intervention(s)

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.

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

Study 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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Primary efficacy endpoint - non-CLI group — 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 — 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 — 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 — 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

Trial sites (7)

Facility	City	Region	Status
Halle	Halle	Saxony-Anhalt	Recruiting
Eilenburg	Eilenburg	Germany	Recruiting
Department of Angiology, University Hospital Leipzig,	Leipzig	Germany	Recruiting
Elblandklinikum Radebeul	Radebeul	Germany	Recruiting
Elblandklinikum Radebeul	Riesa	Germany	Recruiting
REGIOMED Klinikum Sonneberg	Sonneberg	Germany	Recruiting
KKH Torgau	Torgau	Germany	Recruiting

Other trials for the same condition

Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry Active, not recruiting

SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study Active, not recruiting

Trial to Assess the Safety and Efficacy of Sirolimus-Coated Balloon vs. Uncoated Standard Angioplasty for the Treatment of Below-the-knee Peripheral Arterial Disease Active, not recruiting

BIOTRONIK Dynetic-35 Stent for the Treatment of Peripheral Iliac Lesions Active, not recruiting

Sirolimus- vs. Paclitaxel-Drug Coated Ballons in Patients With Peripheral Artery Disease Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04393389 on ClinicalTrials.gov ↗ ← All trials in Germany