Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT04393389

Acotec DCB Post Market Clinical Follow-up

Sponsor: Acotec Scientific Co., Ltd

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

3000

Start Date

2020-06-04

Completion Date

2027-03-01

Last Updated

2024-08-01

Healthy Volunteers

No

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

Locations (7)

Halle

Halle, Saxony-Anhalt, Germany

Eilenburg

Eilenburg, 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, Germany