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Acotec DCB Post Market Clinical Follow-up

NCT04393389 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2024-08-01

No results posted yet for this 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

Conditions

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

Sponsors & Collaborators

  • Acotec Scientific Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Schmidt Andrej · Department of Angiology, University Hospital Leipzig

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-04
Primary Completion
2025-12-01
Completion
2027-03-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04393389 on ClinicalTrials.gov