Recruiting NCT04393389
Acotec DCB Post Market Clinical Follow-up
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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..
- Who it may be relevant to
- Registry conditions: Peripheral Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- 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
Primary outcome measures
- Primary efficacy endpoint - non-CLI group [Time frame: 12 Months]
- Primary efficacy endpoint -CLI group [Time frame: 6 Months]
- Primary safety endpoint- non-CLI group [Time frame: 30 days]
- Primary safety endpoint- CLI group [Time frame: 12 Months]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 7 centers
- Halle — Halle
- Eilenburg — Eilenburg
- Department of Angiology, University Hospital Leipzig, — Leipzig
- Elblandklinikum Radebeul — Radebeul
- Elblandklinikum Radebeul — Riesa
- REGIOMED Klinikum Sonneberg — Sonneberg
- KKH Torgau — Torgau
Identifiers
NCT: NCT04393389 · Acotec-07