Clinical trial NCT04393389: Acotec DCB Post Market Clinical Follow-up
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Artery Disease
Lead sponsor: Acotec Scientific Co., Ltd
Sponsor class: INDUSTRY
First posted: 2020-05-19
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with symptomatic arterial disease undergoing endovascular lower limb revascularization per the institution's standard practice.

Brief 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

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.

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.

Primary outcomes:
measure: Primary efficacy endpoint - non-CLI group
timeFrame: 12 Months
measure: Primary efficacy endpoint -CLI group
timeFrame: 6 Months
measure: Primary safety endpoint- non-CLI group
timeFrame: 30 days
measure: Primary safety endpoint- CLI group
timeFrame: 12 Months
Secondary outcomes:
measure: Rate of Any TLR (including clinically-driven and incidental TLR)
timeFrame: 6 months,12 months,24 months, 36months,48 months,60 months
measure: Rate of Target vessel revascularization (TVR)
timeFrame: 6 months,12 months,24 months, 36months,48 months,60 months
measure: Rate of Target limb revascularization
timeFrame: 6 months,12 months,24 months, 36months,48 months,60 months
measure: Rate of CD-TLR
timeFrame: 6 months,12 months,24 months, 36months,48 months,60 months
measure: Rate of All-cause mortality
timeFrame: 6 months,12 months,24 months, 36months,48 months,60months
measure: Rate of Device- or procedure-related death
timeFrame: 30 days, 6 months
measure: Rate of Major amputation
timeFrame: 6 months,12 months,24 months, 36months,48 months,60 months
measure: Rate of Technical success
timeFrame: Post procedure
measure: Rate of Procedural success
timeFrame: Post procedure
measure: Change in Rutherford clinical category (target limb)
timeFrame: 6 months,12 months,24 months, 36months,48 months,60 months
measure: Rate of primary sustained clinical improvement
timeFrame: 6 months,12 months,24 months, 36months,48 months,60 months
measure: Rate of secondary sustained clinical improvement
timeFrame: 6 months,12 months,24 months, 36months,48 months,60 months
measure: Rate of (Major) Amputation-free survival - CLI group
timeFrame: 6 months,12 months,24 months, 36months,48 months,60 months
measure: Rate of Minor amputation - CLI group
timeFrame: 6 months,12 months,24 months, 36months,48 months,60 months
measure: Rate of Wound healing - CLI group
timeFrame: 60 months
measure: New or recurrent wound of the target limb - CLI group
timeFrame: 60 months
Other outcomes:
Locations:
city: Halle
country: Germany
facility: Halle
state: Saxony-Anhalt
city: Eilenburg
country: Germany
facility: Eilenburg
city: Leipzig
country: Germany
facility: Department of Angiology, University Hospital Leipzig,
city: Radebeul
country: Germany
facility: Elblandklinikum Radebeul
city: Riesa
country: Germany
facility: Elblandklinikum Radebeul
city: Sonneberg
country: Germany
facility: REGIOMED Klinikum Sonneberg
city: Torgau
country: Germany
facility: KKH Torgau
Study officials:
affiliation: Department of Angiology, University Hospital Leipzig
name: Schmidt Andrej
role: PRINCIPAL_INVESTIGATOR
References: