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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00407940
Other study ID # 007A
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date December 2006
Est. completion date October 2007

Study information

Verified date June 2019
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. 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.


Description:

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Study Design


Intervention

Device:
Lower extremity Atherectomy and Cryoplasty


Locations

Country Name City State
United States University of California, San Diego Medical Center, Hillcrest San Diego California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (3)

Laird J, Jaff MR, Biamino G, McNamara T, Scheinert D, Zetterlund P, Moen E, Joye JD. Cryoplasty for the treatment of femoropopliteal arterial disease: results of a prospective, multicenter registry. J Vasc Interv Radiol. 2005 Aug;16(8):1067-73. — View Citation

Muradin GS, Bosch JL, Stijnen T, Hunink MG. Balloon dilation and stent implantation for treatment of femoropopliteal arterial disease: meta-analysis. Radiology. 2001 Oct;221(1):137-45. — View Citation

Zeller T, Rastan A, Schwarzwälder U, Frank U, Bürgelin K, Amantea P, Müller C, Flügel PC, Neumann FJ. Percutaneous peripheral atherectomy of femoropopliteal stenoses using a new-generation device: six-month results from a single-center experience. J Endovasc Ther. 2004 Dec;11(6):676-85. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Ankle Brachial Index (ABI) improvement by =0.15 at 3, 6 and 12 months compared to baseline
Secondary Change in Walking Impairment Questionnaire (WIQ) functional status scores from baseline at 3, 6 and 12 months
Secondary Complications: defined as adverse events (AEs) or serious adverse events (SAEs). Complications may or may not be device related
Secondary Cost to patient and hospital: Including operating room times and duration of hospitalization.
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