RestenosisSALVAGENCT00712257
Study to Evaluate the Safety and Performance of Spectranetics Laser w/Adjunct PTA and Gore Viabahn Endoprosthesis for Treatment of SFA Instent Restenosis
A study testing Spectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface in people with Restenosis, run by VIVA Physicians at 1 site in United States.
Trial summary
A Multicenter study to evaluation the safety and performance of Spectranetics Laser with Adjunct PTA and Gore Viabahn Endoprosthesis for the Treatment of SFA Instent Restenosis Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Restenosis
- What is being tested?
- Spectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Aug 2009
- Phase
- Interventional
- 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
- Subject or subject's legal representative informed of the study nature.
- Subject understands the duration of the study and its follow up visit requirements.
- Intermittent claudication extending through critical limb ischemia meeting a Rutherford 2-5 category.
- Subject able to walk unassisted.
- Female subjects of childbearing potential must have a negative serum pregnancy test 7 days prior to treatment.
Who cannot join
- Life expectancy less than 12 months
- Myocardial infarction less than 3 months prior to procedure
- Known allergies or sensitivities to heparin, aspirin, other anti-coagulant/antiplatelet therapies and nitinol.
- Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
- Uncontrolled hypercoagulability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicenter Trial to Evaluate the Safety and Performance of Spectranetics Laser With Adjunct PTA and GORE VIABAHN Endoprosthesis for the Treatment of SFA Instent Restenosis.
A Multicenter study to evaluation the safety and performance of Spectranetics Laser with Adjunct PTA and Gore Viabahn Endoprosthesis for the Treatment of SFA Instent Restenosis
- Conditions
- Restenosis
- Being tested
- Spectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface
- Keywords
- treatment of superficial femoral artery instent restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive SurfaceDevice
treatment for superficial femoral artery instent re-stenosis
| Study group | Role | What they receive |
|---|---|---|
| Spectranetics Laser plus Gore Viabahn Endoprosthesis | Other | Spectranetics Laser for optimal debulking followed by adjunctive PTA plus GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface placement Receives: Device: Spectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month duplex-ultrasound defined target lesion patency will be assessed in the enrollment arm. Patency is defined as a ratio of less than 2.0, measured as the upstream peak systolic velocity compared with PSV in the area of greatest stenosis.
Measured: 12 months
Secondary outcomes (1)
Target lesion revascularization will be evaluated at 12 mos. and defined as any pecutaneous or surgical intervention to treat a stenosis or cocclusion of the arget lesion treated at the index procedure.
Measured: 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startNov 2007
- Primary completionSep 2008
- Study completionAug 2009
Why it stopped: Due to safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RestenosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVA Physicians
- Sponsor type
- University, hospital or other
- Collaborators
- W.L.Gore & Associates, Spectranetics Corporation
- Responsible party
- Sponsor
- Investigators
- Tony Das, MD, Principal investigator, Presbyterian Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712257
- Sponsor's protocol ID
- SALVAGE - 00106-661
- Acronym
- SALVAGE
- Status last verified
- Jun 2014
- First submitted
- 3 Jul 2008
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Trial to Evaluate the Safety and Performance of Spectranetics Laser With Adjunct PTA and GORE VIABAHN Endoprosthesis for the Treatment of SFA Instent Restenosis.
- ClinicalTrials.gov ID
- NCT00712257
- Acronym / sponsor ID
- SALVAGE / SALVAGE - 00106-661
- Conditions
- Restenosis
- Keywords
- treatment of superficial femoral artery instent restenosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to safety concerns
- Enrolment
- 27 participants (actual)
- Lead sponsor
- VIVA PhysiciansUniversity, hospital or other
- Collaborators
- W.L.Gore & Associates, Spectranetics Corporation
- Study start
- Nov 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 9 Jul 2008 (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.
A Multicenter study to evaluation the safety and performance of Spectranetics Laser with Adjunct PTA and Gore Viabahn Endoprosthesis for the Treatment of SFA Instent Restenosis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spectranetics Laser plus Gore Viabahn Endoprosthesis | Other | Device: Spectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive SurfaceSpectranetics Laser for optimal debulking followed by adjunctive PTA plus GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface placement |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject or subject's legal representative informed of the study nature.
- Subject understands the duration of the study and its follow up visit requirements.
- Intermittent claudication extending through critical limb ischemia meeting a Rutherford 2-5 category.
- Subject able to walk unassisted.
- Female subjects of childbearing potential must have a negative serum pregnancy test 7 days prior to treatment.
Key exclusion criteria (5 listed)
- Life expectancy less than 12 months
- Myocardial infarction less than 3 months prior to procedure
- Known allergies or sensitivities to heparin, aspirin, other anti-coagulant/antiplatelet therapies and nitinol.
- Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
- Uncontrolled hypercoagulability
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 |
|---|---|---|
| Spectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surfacetreatment for superficial femoral artery instent re-stenosis | Device | Spectranetics Laser plus Gore Viabahn Endoprosthesis |
Primary outcome
12-month duplex-ultrasound defined target lesion patency will be assessed in the enrollment arm. Patency is defined as a ratio of less than 2.0, measured as the upstream peak systolic velocity compared with PSV in the area of greatest stenosis.
Time frame: 12 months
1 secondary outcome
Target lesion revascularization will be evaluated at 12 mos. and defined as any pecutaneous or surgical intervention to treat a stenosis or cocclusion of the arget lesion treated at the index procedure.
Time frame: 12 month follow up
Results and safety
The study was stopped early (reason given: Due to safety concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2014.
Related trials for Restenosis
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Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
Not yet recruitingObservational study
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal In-Stent Restenosis (ISR)
Active, not recruitingPhase 3
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
In-Stent Restenosis
Active, not recruitingPhase 3
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort
In-Stent Restenosis
Not yet recruitingObservational study
The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
Chronic Venous Disease, Chronic Venous Insufficiency, CVI
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.
Tony Das, MD principal investigator
Presbyterian Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectranetics Laser with adjunct PTA and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface in people with Restenosis, 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: stopped early, as of the sponsor's last update on 4 Jun 2014. 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.
Are results available for this study?
The study was stopped early (reason given: Due to safety concerns). Results are not available in the source record.
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?
12-month duplex-ultrasound defined target lesion patency will be assessed in the enrollment arm. Patency is defined as a ratio of less than 2.0, measured as the upstream peak systolic velocity compared with PSV in the area of greatest stenosis. (time frame: 12 months). 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 4 Jun 2014.