NCT04361071

Brief Summary

This is a randomized study comparing stent and plaque excision systems in treatment of Iliac artery occlusive disease.

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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 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

First Submitted

Initial submission to the registry

December 27, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 24, 2020

Status Verified

August 1, 2019

Enrollment Period

4.3 years

First QC Date

December 27, 2017

Last Update Submit

April 22, 2020

Conditions

Iliac Artery Occlusion

Keywords

stentatherectomyiliac Artery

Outcome Measures

Primary Outcomes (2)

  • 12-month Primary Patency Rate

    Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven target vessel revascularization performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis \>50% with a peak systolic velocity ratio \>2.4 as measured by Duplex ultrasound.

    12 months

  • 12-month Limb Salvage Rate

    Limb Salvage is defined as the freedom from secondary major amputation

    12 months

Secondary Outcomes (3)

  • Index Limb Ischemia at 6-month Follow up

    6 months

  • Index Limb Ischemia at 12-month Follow up

    12 months

  • Major Adverse Events at 12-month Post Procedure

    12 months

Study Arms (2)

Stent

ACTIVE COMPARATOR

Stent group

Device: stent

Atherectomy

ACTIVE COMPARATOR

Atherectomy group

Device: plaque excision system

Interventions

stentDEVICE

stent

Stent
plaque excision systemDEVICE

plaque excision system

Atherectomy

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patients have non thrombotic arteriosclerosis obliterans of the common iliac or external iliac arteries
  • Clinical diagnosis of stenosis or occlusive disease
  • The patients have unobstructed distal outflow tract
  • Receiving surgical treatment at the same time

You may not qualify if:

  • The patients who have previously implanted stent(s) or stent graft(s) in target leg
  • Life expectancy less than 12 months
  • Has any planned surgical or endovascular intervention of target vessel 30 days before or after index procedure
  • Thrombophlebitis, uremia, or deep venous thrombus, within past 30 days
  • Receiving dialysis or immunosuppressant therapy
  • Recent stroke within past 90 days
  • Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®) or ticlopidine (Ticlid®), heparin, Nitinol (nickel titanium), contrast agent, that cannot be medically managed
  • Tissue loss due to ischemic disease (Rutherford/Becker category 5 or 6)
  • Serum creatinine level \>/= 2.5 mg/dl at time of screening visit
  • Known or suspected active infection at the time of the procedure
  • Bleeding diathesis
  • Patient is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol.
  • Patients are known to be pregnant, incarcerated, mentally incompetent, and/or alcohol or drug abuser.
  • Patients are currently participating in any other investigational drug or medical device study that has not completed primary endpoint(s) evaluation or clinically interferes with the endpoints from this study or future participation in such studies prior to the completion of this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yongquan Gu

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Interventions

Stents

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Central Study Contacts

Jianming Guo, M.D.

CONTACT

13146369562guojianming1020@icloud.com

Yongquan 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

December 27, 2017

First Posted

April 24, 2020

Study Start

August 1, 2018

Primary Completion

December 1, 2022

Study Completion

December 1, 2023

Last Updated

April 24, 2020

Record last verified: 2019-08

Locations

CN(1)