Back to results

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)

Primary Purpose

Chronic Critical Limb Ischemia, Peripheral Vascular Diseases

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Xpert(TM) Self-expanding Transhepatic Biliary Stent System feasibility in treating chronic critical limb ischemia

About this trial

This is an interventional treatment trial for Chronic Critical Limb Ischemia focused on measuring CLI, Critical Limb Ischemia

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

VIVA Physicians Inc.

Outcomes

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.

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

Full Information

NCT ID

NCT00515346

First Posted

August 9, 2007

Last Updated

December 16, 2013

Sponsor

VIVA Physicians

Collaborators

Prairie Education and Research Cooperative

1. Study Identification

Unique Protocol Identification Number

NCT00515346

Brief Title

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.

Acronym

XCELL

Official Title

Phase 1 Study of Xpert(TM) Nitinol Stenting for Critically Ischemic Lower Limbs

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VIVA Physicians

Collaborators

Prairie Education and Research Cooperative

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Critical Limb Ischemia, Peripheral Vascular Diseases

Keywords

CLI, Critical Limb Ischemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Xpert(TM) Self-expanding Transhepatic Biliary Stent System feasibility in treating chronic critical limb ischemia

Primary Outcome Measure Information:

Title

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James D. Joye, DO

Organizational Affiliation

VIVA Physicians Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

VIVA Physicians Inc.

City

San Jose

State/Province

California

ZIP/Postal Code

95123

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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.

We'll reach out to this number within 24 hrs