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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00407940
Date of registration: 04/12/2006
Primary sponsor: University of California, San Diego
Public title: ATHERO: Advanced Technology Halting Early Re-Stenosis and Occlusion
Scientific title: ATHERO: Advanced Technology Halting Early Re-Stenosis and Occlusion. A Prospective Randomized Trial Comparing Silverhawk™ Atherectomy to CryoPlasty® Therapy for Lower Extremity Claudication
Date of first enrolment: December 2006
Target sample size: 100
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT00407940
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Countries of recruitment
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Arterial Occlusive Disease
Intermittent Claudication
Intervention(s)
Device: Lower extremity Atherectomy and Cryoplasty
Primary Outcome(s)
Primary target patency at 12 months. The “target” is the index stenotic lesion(s). Primary patency is defined as <50% residual stenosis by duplex (color-flow Doppler) scan analysis, with antegrade flow to the target vessel.
Secondary Outcome(s)
Ankle Brachial Index (ABI) improvement by =0.15 at 3, 6 and 12 months compared to baseline
Change in Walking Impairment Questionnaire (WIQ) functional status scores from baseline at 3, 6 and 12 months
Complications: defined as adverse events (AEs) or serious adverse events (SAEs). Complications may or may not be device related
Cost to patient and hospital: Including operating room times and duration of hospitalization.
Secondary ID(s)
007A
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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