NCT05575245

Brief Summary

This is a Prospective randomized controlled study to evaluate the difference of safety，effectiveness between Excimer Laser Ablation Combined Drug-coated Balloon and drug-eluting stent in treatment of femoral-popliteal artery lesions.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

March 3, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2024

Completed
Last Updated

December 7, 2022

Status Verified

December 1, 2022

Enrollment Period

2.6 years

First QC Date

August 10, 2022

Last Update Submit

December 4, 2022

Conditions

AtherosclerosisIschemia

Keywords

drug-eluting 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

    1 day

  • freedom from clinically-driven TLR

    1 day

  • Major Adverse Events at 12-month Post Procedure

    12 months

  • 12-month Limb Salvage Rate

    12 months

Study Arms (2)

Intervention: Drug-eluting Stent

ACTIVE COMPARATOR

Drug-eluting Stent group

Device: Drug-eluting Stent

Intervention: Excimer Laser Ablation Combined Drug-coated Balloon

EXPERIMENTAL

Excimer Laser Ablation Combined Drug-coated Balloon group

Device: Excimer Laser Ablation Combined Drug-coated Balloon

Interventions

Drug-eluting StentDEVICE

Drug-eluting Stent angioplasty

Intervention: Drug-eluting Stent
Excimer Laser Ablation Combined Drug-coated BalloonDEVICE

Excimer Laser Ablation Combined Drug-coated Balloon angioplasty

Intervention: Excimer Laser Ablation Combined 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

Location

MeSH Terms

Conditions

AtherosclerosisIschemia

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies
0

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

August 10, 2022

First Posted

October 12, 2022

Study Start

March 3, 2022

Primary Completion

October 20, 2024

Study Completion

October 20, 2024

Last Updated

December 7, 2022

Record last verified: 2022-12

Locations

CN(1)