NCT05158257

Brief Summary

This is a Prospective randomized controlled study to evaluate the difference of safety，effectiveness between endovascular debulking combined drug-coated balloon and balloon dilatation combined stent angioplasty in treatment of femoral-popliteal artery lesions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

2 years

First QC Date

October 7, 2021

Last Update Submit

October 9, 2022

Conditions

AtherosclerosisIschemia

Keywords

stentdebulkingfemoral arterydrug-coated balloon

Outcome Measures

Primary Outcomes (1)

  • 12-month Primary Patency Rate

    systolic velocity ratio \>2.4 as measured by Duplex ultrasound.

    12 months

Secondary Outcomes (4)

  • Technical success rate

    1 day

  • freedom from clinically-driven TLR rate

    12 months

  • Major Adverse Events at 12-month Post Procedure

    12 months

  • 12-month Limb Salvage Rate

    12 months

Study Arms (2)

Intervention: balloon and Stents

ACTIVE COMPARATOR

plain balloon and Stents group

Device: balloon and Stent

Intervention: debulking and drug coated balloon

EXPERIMENTAL

debulking and drug coated balloon group

Device: endovascular debulking and DCB

Interventions

balloon and StentDEVICE

balloon dilatation combined stent angioplasty

Intervention: balloon and Stents
endovascular debulking and DCBDEVICE

endovascular debulking combined drug-coated balloon

Intervention: debulking and drug coated balloon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gu Yong Quan

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

AtherosclerosisIschemia

Interventions

Stents

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Central Study Contacts

yang Li, M.D.

CONTACT

18810432268liyang0603@aliyun.com

Yong quan Gu, M.D.

CONTACT

1590159820915901598209@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2021

First Posted

December 15, 2021

Study Start

September 30, 2021

Primary Completion

October 10, 2023

Study Completion

December 1, 2023

Last Updated

October 12, 2022

Record last verified: 2022-10

Locations

CN(1)