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Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia

TerminatedPhase 4NCT00504088
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs

Study details

Official title
Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia
Conditions
  • Peripheral Vascular Diseases
Interventions
  • Procedure: Bypass
  • Procedure: Silverhawk Plaque Excision
Sponsor
FoxHollow Technologies
Start date
2006-10
Sex
All
Age range
from 18 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
31

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Ischemic rest pain for more than 2 weeks or ulceration or gangrene of the foot or toes (Rutherford Becker Category 4, 5 or 6) * Willing and able, as evaluated by the PI, to provide Informed Consent * Willing to undergo up to 5 years of clinical follow up visits as scheduled * Angiographic pattern of infrainguinal disease that can be reasonably managed either by surgery or plaque excision in the first instance * Reconstitution of at least one patent target tibial segment below the knee which provides run-off to the foot * The patient must be \>18 years of age * Target lesion(s) is located at or below the level of the superficial femoral artery * Target lesion(s) is \>50% stenosed by quantitative vascular angiography * Ability to take at least one of the following types of medications: anti- platelet or anti-thrombotic therapy Exclusion Criteria: * Patient has cardiac or cardiovascular comorbidities that would make surgery inappropriate * Patient has terminal or Stage 4 cancer * Patient has extensive gangrene that requires both a Below-the-Knee amputation and a revascularization procedure * Previous stent in the target lesion * Active infection at planned incision site * The patient is a pregnant woman * The patient has significant suprainguinal or Common Femoral disease that can not be treated either prior to or during the index procedure * Target Lesion is a Chronic Total Occlusion (CTO) that is greater than 15cm in length and has severe, continuous calcification

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00504088