Chronic Critical Limb IschemiaPhase 1XCELLNCT00515346
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.
A Phase 1 study testing Xpert(TM) Self-expanding Transhepatic Biliary Stent System feasibility in treating chronic critical limb ischemia in people with Chronic Critical Limb Ischemia and Peripheral Vascular Diseases, run by VIVA Physicians at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Chronic Critical Limb Ischemia, Peripheral Vascular Diseases
- What is being tested?
- Xpert(TM) Self-expanding Transhepatic Biliary Stent System feasibility in treating chronic critical limb ischemia
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Sep 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Being tested
- Xpert(TM) Self-expanding Transhepatic Biliary Stent System feasibility in treating chronic critical limb ischemia
- Keywords
- CLI, Critical Limb Ischemia
- Medical subject headings
- Peripheral Vascular Diseases, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xpert(TM) Self-expanding Transhepatic Biliary Stent System feasibility in treating chronic critical limb ischemiaDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2007 (estimated)
- Study startJul 2006
- Primary completionDec 2009
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Critical Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVA Physicians
- Sponsor type
- University, hospital or other
- Collaborators
- Prairie Education and Research Cooperative
- Responsible party
- Sponsor
- Investigators
- James D. Joye, DO, Principal investigator, VIVA Physicians Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515346
- Sponsor's protocol ID
- G060029
- Acronym
- XCELL
- Status last verified
- Dec 2013
- First submitted
- 9 Aug 2007
- Last updated
- 18 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Xpert(TM) Nitinol Stenting for Critically Ischemic Lower Limbs
- ClinicalTrials.gov ID
- NCT00515346
- Acronym / sponsor ID
- XCELL / G060029
- Keywords
- CLI, Critical Limb Ischemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- VIVA PhysiciansUniversity, hospital or other
- Collaborators
- Prairie Education and Research Cooperative
- Study start
- Jul 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 13 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xpert(TM) Self-expanding Transhepatic Biliary Stent System feasibility in treating chronic critical limb ischemia | Device | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
- Click here for more information about this studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James D. Joye, DO principal investigator
VIVA Physicians Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Xpert(TM) Self-expanding Transhepatic Biliary Stent System feasibility in treating chronic critical limb ischemia in people with Chronic Critical Limb Ischemia and Peripheral Vascular Diseases, run by VIVA Physicians at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.