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

August 9, 2007
December 16, 2013
July 2006
December 2009   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00515346 on ClinicalTrials.gov Archive Site
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 ]
Assess improvement in Wound healing; assess restenosis; Measure Target lesion revascularization to maintain patency as 12 mos.; Measure Ankle/Brachial improvement level; Assess Stent Integrity; Characterize improvement in Health Related Quality of Life. [ Time Frame: 2 years ]
Not Provided
Not Provided
 
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.
Phase 1 Study of Xpert(TM) Nitinol Stenting for Critically Ischemic Lower Limbs

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).

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Critical Limb Ischemia
  • Peripheral Vascular Diseases
Device: Xpert(TM) Self-expanding Transhepatic Biliary Stent System feasibility in treating chronic critical limb ischemia
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
September 2011
December 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00515346
G060029
Yes
VIVA Physicians
VIVA Physicians
Prairie Education and Research Cooperative
Principal Investigator: James D. Joye, DO VIVA Physicians Inc.
VIVA Physicians
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP