NCT06009146

Brief Summary

This study is a prospective, multi-center observational study, which evaluates the effectiveness and safety of endovascular therapy in the real world for infrapopliteal arterial occlusive disease from intermittent claudication to chronic threatening limb ischemia.

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
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Typical duration for all trials

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

July 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

1.3 years

First QC Date

August 20, 2023

Last Update Submit

August 20, 2023

Conditions

Infrapopliteal Artery Occlusive DiseaseEndovascular Treatment

Keywords

Endovascular TreatmentInfrapopliteal Artery DiseaseDrug-coated BalloonsAngioplastyAtherectomy

Outcome Measures

Primary Outcomes (1)

  • Freedom from major adverse event rate

    Major adverse events include Death, major amputation rates and clinical driven target lesion revascularization (CDTLR).

    12 months

Secondary Outcomes (9)

  • Amputation-free survival

    12 months

  • Survival

    12 months

  • Freedom from major amputation

    12 months

  • Freedom from CDTLR

    12 months

  • Freedom from clinical driven target limb revascularization

    12 months

  • +4 more secondary outcomes

Study Arms (3)

Rutherford scale < 4

Device: Endovascular treatment

Rutherford scale 4-5

Device: Endovascular treatment

Rutherford scale 6

Device: Endovascular treatment

Interventions

Endovascular treatmentDEVICE

Endovascular treatment for infrapopliteal arterial disease.

Rutherford scale 4-5Rutherford scale 6Rutherford scale < 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with infrapopliteal arterial occlusive disease undergoing endovascular treatment.

You may qualify if:

  • Patients ≥ 18 years of age; Patients with ≥1 infrapopliteal artery disease (P3 popliteal artery, anterior tibial artery, posterior tibial artery, peroneal artery, tibiofibular trunk) need to receive endovascular treatment, regardless of whether there is a combination of supra-knee or submalleolar occlusion; Patients voluntary and capable of follow-up;

You may not qualify if:

  • Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc., and those who are unable to undergo endovascular therapy for other reasons; Pregnant and lactating women; Patients with thromboangiitis obliterans；

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Study Officials

  • Lianrui Guo, M.D.

    Xuanwu Hospital, Beijing

    STUDY CHAIR

Central Study Contacts

Lianrui Guo, M.D.

CONTACT

+8613671009746lianruiguo@sina.com

Xixiang Gao, M.D.

CONTACT

+8613581674309vascsurgeon@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2023

First Posted

August 24, 2023

Study Start

July 1, 2023

Primary Completion

October 1, 2024

Study Completion

October 1, 2025

Last Updated

August 24, 2023

Record last verified: 2023-08

Locations

CN(1)