ATHERO: Advanced Technology Halting Early Re-Stenosis and Occlusion

Withdrawn before enrolling · Phase 4

Conditions studied: Arterial Occlusive Disease, Intermittent Claudication

In brief

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. Comparable devices are selected for patient use somewhat arbitrarily, often dependent on industry influence. An unmet need is NON-industry sponsored prospective trials COMPARING devices head-to-head so that endovascular surgeons can even contemplate evidence-based device selection. At present, we seek to compare two new high-technology devices that are indicated to treat lower extremity arterial stenoses associated with claudication.

Key facts

Study ID

NCT00407940

Run by

University of California, San Diego

People needed

0

Starts

2006-12-01

Expected to finish

2007-10-01

Last updated by the study team

2019-06-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California, San Diego Medical Center, Hillcrest — San Diego, California, United States

Full record on ClinicalTrials.gov

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