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)

This study has been completed.
Sponsor:
Collaborator:
Prairie Education and Research Cooperative
Information provided by (Responsible Party):
VIVA Physicians
ClinicalTrials.gov Identifier:
NCT00515346
First received: August 9, 2007
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of Xpert(TM) Nitinol Stenting for Critically Ischemic Lower Limbs

Resource links provided by NLM:


Further study details as provided by VIVA Physicians:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: July 2006
Study Completion Date: September 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515346

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

No publications provided

Responsible Party: VIVA Physicians
ClinicalTrials.gov Identifier: NCT00515346     History of Changes
Other Study ID Numbers: G060029
Study First Received: August 9, 2007
Last Updated: December 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by VIVA Physicians:
CLI
Critical Limb Ischemia

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

ClinicalTrials.gov processed this record on April 17, 2014