Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia

Carelon Research160 sites in 1 country1,843 target enrollmentAugust 2014

ConditionsCritical Limb Ischemia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Critical Limb Ischemia
Sponsor: Carelon Research
Enrollment: 1843
Locations: 160
Primary Endpoint: The primary efficacy endpoint: MALE (Major Adverse Limb Event)-free survival. MALE is defined as above ankle amputation of the index limb or major re-intervention (e.g. new bypass graft, jump/interposition graft revision, or thrombectomy/ thrombolysis)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will compare the effectiveness of best available surgical treatment with best available endovascular treatment in adults with critical limb ischemia (CLI) who are eligible for both treatment options.

Detailed Description

Male and female subjects aged 18 years or older will be randomized to receive either open surgical treatment or endovascular treatment. They will be followed for at least 2 years and up to 4 years and 2 months after treatment to primarily assess survival and major adverse limb events in the index or treated limb, and secondarily, to determine clinical and cost effectiveness outcomes after treatment. These outcomes (survival-free of major limb events and clinical, functional and cost effectiveness) will be compared within two cohorts of subjects: those with an available single-segment great saphenous vein, and those with an alternative conduit. The null hypotheses for both cohorts is that there will be no difference in MALE-free survival between best endovascular therapy and best surgical therapy.

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

March 1, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Carelon Research

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female, age 18 years or older.
•Infrainguinal PAOD (occlusive disease of the arteries below the inguinal ligament).
•CLI, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain consistent with Rutherford categories 4-
•Candidate for both endovascular and open infrainguinal revascularization as judged by the treating investigators
•Adequate aortoiliac inflow.
•Adequate popliteal, tibial or pedal revascularization target defined as an infrainguinal arterial segment distal to the area of stenosis/occlusion which can support a distal anastomosis of a surgical bypass.
•Willingness to comply with protocol, attend follow-up appointments, complete all study assessments, and provide written informed consent.

Exclusion Criteria

•Presence of a popliteal aneurysm (\>2 cm) in the index limb.
•Life expectancy of less than 2 years due to reasons other than PAOD.
•Excessive risk for surgical bypass (as determined by the operating surgeon and the CLI Team)
•Planned above ankle amputation on ipsilateral limb within 4 weeks of index procedure.
•Active vasculitis, Buerger's disease, or acute limb-threatening ischemia
•Any prior index limb infrainguinal stenting or stent grafting associated with significant restenosis within 1 cm of stent or stent-graft, unless the occlusion/restenosis site is outside the intended treatment zone (i.e.,. a tibial vessel that is not currently intended to be revascularized as a part of the treatment for CLI).
•Any of the following procedures performed on the index limb within 3 months prior to enrollment:
•Infrainguinal balloon angioplasty, atherectomy, stent, or stentgraft;
•Infrainguinal bypass with either venous or prosthetic conduit
•Open surgical inflow procedure (aortofemoral, axillofemoral, iliofemoral, thoracofemoral or femorofemoral bypass) within 6 weeks prior to enrollment

Outcomes

Primary Outcomes

The primary efficacy endpoint: MALE (Major Adverse Limb Event)-free survival. MALE is defined as above ankle amputation of the index limb or major re-intervention (e.g. new bypass graft, jump/interposition graft revision, or thrombectomy/ thrombolysis)

Time Frame: Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject

* Time to major adverse limb event or death, whichever occurs first in subjects with Single-Segment Great Saphenous Vein (SSGSV) available * Time to major adverse limb event or death, whichever occurs first in subjects without available SSGSV

Secondary Outcomes

Clinical: Freedom from hemodynamic failure (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Clinical: Freedom from MALE-POD (POD, defined as death within 30 days of index procedure) (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Clinical: Re-intervention and amputation-free survival (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Clinical: Freedom from POD (POD, defined as death within 30 days of index procedure) (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Clinical: Freedom POD (POD, defined as death within 30 days of index procedure) (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Clinical: Freedom from Myocardial Infarction (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Clinical: Freedom from Stroke (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Clinical: Number of re-interventions (major and minor) in per limb salvaged (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Clinical: Freedom from clinical failure (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Functional: Quality of Life assessment using VasuQoL (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Clinical: Re-intervention and amputation-free survival (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Clinical: Number of re-interventions (major and minor) in per limb salvaged (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Clinical: Freedom from clinical failure (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Clinical: Freedom from Critical Limb Ischemia (CLI) (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Clinical: Freedom from all-cause mortality (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Functional: Numerical rating scale for Pain, Worst level of Pain (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Clinical: Clinical: Freedom from MALE-POD (POD, defined as death within 30 days of index procedure) (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Clinical: Amputation-free survival (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Clinical: Amputation-free survival (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Clinical: Freedom from Myocardial Infarction (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Clinical: Freedom from Stroke (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Functional: Quality of Life assessment using EuroQoL (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Functional: Numerical rating scale for Pain, Pain Now (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Functional: Numerical rating scale for Pain, Usual level of Pain (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Functional: Numerical rating scale for Pain, Worst level of Pain (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Clinical: Freedom from re-intervention (major and minor) in index leg (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Clinical: Freedom from re-intervention (major and minor) in index leg (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Clinical: Freedom from hemodynamic failure (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Clinical: Freedom from Critical Limb Ischemia (CLI) (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Functional: Quality of Life assessment using VasuQoL (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Functional: Quality of Life assessment using EuroQoL (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Functional: Function assessment using SF-12, MCS (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Functional: Function assessment using SF-12, SF-6D R2 (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Functional: Numerical rating scale for Pain, Best level of Pain (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Clinical: Freedom from all-cause mortality (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Functional: Function assessment using SF-12, PCS (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Functional: Function assessment using SF-12, PCS (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Functional: Numerical rating scale for Pain, Pain Now (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Functional: Function assessment using SF-12, MCS (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Functional: Function assessment using SF-12, SF-6D R2(cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Functional: Numerical rating scale for Pain, Usual level of Pain (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Functional: Numerical rating scale for Pain, Best level of Pain (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Function: Six-minute walk test (cohort 2)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)
Function: Six-minute walk test (cohort 1)(Through each subject's last regularly scheduled study visit, up to a maximum of 84 months per subject)