Status:
WITHDRAWN
ATHERO: Advanced Technology Halting Early Re-Stenosis and Occlusion
Lead Sponsor:
University of California, San Diego
Conditions:
Arterial Occlusive Disease
Intermittent Claudication
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The rise of minimal access surgery has heralded the approval of a number of endovascular devices with similar indications. This is particularly true for the treatment of lower extremity ischemia. Comp...
Detailed Description
Peripheral arterial disease affects more than 12 million Americans, and its incidence is growing annually. The male/female ratio of patients with claudication is just under 2/1. The arteries involved ...
Eligibility Criteria
Inclusion
- The subject must give written informed consent and possess decision making capacity free of sedative or hypnotic agents.
- Age 18 years or older
- Candidate for angiography with intent-to-treat as determined by the Principle Investigator
- On angiography, ipsilateral to a symptomatic limb, a stenotic or occluded de novo or restenotic lesion in the common femoral artery, superficial femoral artery or above the knee popliteal artery measuring no longer than 10 cm (the upper limit of treatment in Cryoplasty pre-marketing)
- On angiography Lesion stenoses between 50% and 100% (inclusive)
- At least one runoff vessel
- Available for follow-up assessments
Exclusion
- Contraindication to systemic anticoagulation e.g. history of documented hemorrhage requiring treatment within the past 30 days; history of a hereditary bleeding disorder or known bleeding diathesis; major surgery or trauma, open chest massage, ocular surgery or hemorrhagic retinopathy within the past 30 days; puncture at a non-compressible site within 48 hours prior to planned procedure; history of stroke, intracranial hemorrhage, or central nervous system structural abnormalities within the past 3 months
- History of endovascular surgery procedure or open vascular surgery on the index limb within the last 30 days
- History of significant acute or chronic kidney disease that would preclude contrast angiography
- Known allergy to contrast agents
- History of heparin-induced thrombocytopenia (HIT)
- Participation in any study of an investigational device, medication, biologic, or other agent within 30 days prior to randomization
- Any thrombolytic therapy within 30 days of randomization
- Pregnancy, lactation, or possession of any child bearing potential without evidence of surgical infertility or passage of 12 months since the last day of the subject's last menstrual period.
- Target lesion involving a dacron prosthesis or a prosthetic of unknown material
- Target lesion extending into the orifice of the profunda femoris artery
- Prisoner status
- Any other subject feature that in the opinion of the investigator should preclude study participation
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00407940
Start Date
December 1 2006
End Date
October 1 2007
Last Update
June 13 2019
Active Locations (1)
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1
University of California, San Diego Medical Center, Hillcrest
San Diego, California, United States, 92121