NCT04490408

Brief Summary

The present randomized study proposed to compare the immediate postoperative and 2-year clinical outcomes of long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Status
completed

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 20, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2020

Completed
Last Updated

July 29, 2020

Status Verified

July 1, 2020

Enrollment Period

4.6 years

First QC Date

July 24, 2020

Last Update Submit

July 24, 2020

Conditions

Critical Lower Limb Ischemia

Outcome Measures

Primary Outcomes (1)

  • Late occlusion

    Late occlusion of the affected vessels

    2 years

Study Arms (2)

long surgical bypass

ACTIVE COMPARATOR

long surgical bypass for multilevel lower limb ischemia

Procedure: long surgical bypass

Hybrid approach

EXPERIMENTAL

surgical bypass and endovascular treatment for multilevel lower limb ischemia

Procedure: Hybrid approach

Interventions

long surgical bypassPROCEDURE

long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.

long surgical bypass
Hybrid approachPROCEDURE

Hybrid approach including bypass and endovascular revascularization

Hybrid approach

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • TASC II type D femoropopliteal lesions with intact ipsilateral femoral pulse.
  • Fontaine classification stage IV (gangrene or necrosis).
  • Rutherford grade III and IV category 5 and 6 with salvageable foot

You may not qualify if:

  • heart failure
  • liver failure
  • renal impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

July 24, 2020

First Posted

July 29, 2020

Study Start

September 20, 2014

Primary Completion

April 17, 2019

Study Completion

April 17, 2019

Last Updated

July 29, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share