Study to Evaluate the Safety & Performance of the Xpert(TM) Stent in Treating Below-the-knee Lesions in Patients Undergoing Percutaneous Intervention for Chronic CLI. (XCELL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00515346
Recruitment Status : Completed
First Posted : August 13, 2007
Last Update Posted : December 18, 2013
Prairie Education and Research Cooperative
Information provided by (Responsible Party):
VIVA Physicians

Brief Summary:
The purpose of this study is to evaluate the safety and performance of the Xpert(TM) self-expanding stent in infrapopliteal lesions as part of an overall treatment strategy in patients undergoing percutaneous intervention for the treatment of documented chronic critical limb ischemia (CLI).

Condition or disease Intervention/treatment Phase
Chronic Critical Limb Ischemia Peripheral Vascular Diseases Device: Xpert(TM) Self-expanding Transhepatic Biliary Stent System feasibility in treating chronic critical limb ischemia Phase 1

Detailed Description:

Peripheral arterial disease (PAD) of the lower extremities affects roughly 25 million Americans annually. The diabetic population is particularly prone to the most severe clinical problems associated with PAD and the amputation rate amongst such patients is elevated five-fold. It has been shown that patients who undergo amputation for PAD/CLI have a much higher mortality rate in the months that follow.

Despite medical advances in the fields of pharmacology and wound care, the vast majority of patients who present with CLI will ultimately require amputation in the absence of improved blood flow. Recently, much attention has been directed towards less invasive endovascular solutions for treating patients with CLI. This study will evaluate approximately 140 subjects with Rutherford Class IV-VI PAD in a multi-center study in order to accurately estimate limb salvage rates for this treatment.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Xpert(TM) Nitinol Stenting for Critically Ischemic Lower Limbs
Study Start Date : July 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : September 2011

Primary Outcome Measures :
  1. Amputation free survival at 12 months in the target limb. Amputation for the primary endpoint is defined as a major, unplanned, amputation of the target limb through the 12 month visit where prosthesis is required for standing or walking. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Assess improvement in wound healing; assess restenosis; measure target lesion revascularization to maintain patency at 12 months; measure ankle/brachial improvement level; assess stent integrity; characterize improvement in health related quality of life [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient has documented wound care greater than or equal to 2 weeks prior to enrollment
  • Subject understands the duration of the study and its follow up visit requirements
  • Female subjects of childbearing potential have a negative pregnancy test less than 7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation
  • Subject has documented chronic critical limb ischemia in the target limb for two weeks with Rutherford Category 4, 5 or 6
  • Subject must have one of 5 approved non-invasive test results of the target limb within two weeks of enrollment.

Exclusion Criteria:

  • Life expectancy of less than 12 months
  • Cerebrovascular accident (CVA) or myocardial infarction (MI) within 3 months prior to enrollment
  • Inability to walk (with assistance is accepted)
  • Previous bypass surgery to target limb less than 30 days prior to study procedure
  • Acute thrombus at the lesion site(s)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00515346

United States, California
VIVA Physicians Inc.
San Jose, California, United States, 95123
Sponsors and Collaborators
VIVA Physicians
Prairie Education and Research Cooperative
Principal Investigator: James D. Joye, DO VIVA Physicians Inc.

Responsible Party: VIVA Physicians Identifier: NCT00515346     History of Changes
Other Study ID Numbers: G060029
First Posted: August 13, 2007    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: December 2013

Keywords provided by VIVA Physicians:
Critical Limb Ischemia

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Cardiovascular Diseases
Arterial Occlusive Diseases