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ACOART BTK RENEW：A Post Market Clinical Study

NCT04885985 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2024-08-01

No results posted yet for this study

Summary

The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Acotec Litos\&Tulip Drug-coated Balloon catheters in the treatment of lesions in below-the-knee artery.

Conditions

Interventions

DEVICE

DEB catheter

Trade name of DEB catheter: AcoArt Tulip (0.018") or AcoArt Litos (0.014")

Sponsors & Collaborators

  • Acotec Scientific Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Zhuang Baixi · Xiyuan Hospital of China Academy of Chinese Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2024-08-01
Completion
2027-04-01

Countries

  • China

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 NCT04885985 on ClinicalTrials.gov