Femoropopliteal In-Stent RestenosisPhase 1NCT01962389
First in Human Study of Winsor Laser Catheter: A Prospective Registry to Evaluate The Safety and Performance of the Winsor Laser Catheter in the Treatment of In-Stent Restenosis
A Phase 1 study testing Winsor Laser Catheter in people with Femoropopliteal In-Stent Restenosis, run by Spectranetics Corporation at 1 site in Colombia.
Trial summary
The study will evaluate the procedural safety and efficacy of the Winsor Laser Catheters for the treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA) Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Femoropopliteal In-Stent Restenosis
- What is being tested?
- Winsor Laser Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteColombia
- Study dates
- Jan 2014to Apr 2014
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age ≥ 18 years.
- Rutherford Category 2-4.
- Subject has been informed of the nature of the study, agrees to participate and has signed an Ethics Committee approved informed consent form.
- Documentation of significant ISR defined as >50% stenosis and >5 cm in length determined by diagnostic angiogram or duplex ultrasound.
- A previously deployed bare nitinol stent(s) in the femoropopliteal segment extending from the ostium of the SFA to 1 cm above the tibioperoneal trunk. A guidewire has successfully traversed the target treatment segment, or is able to cross using standard support catheter crossing techniques, is angiographically documented to be within true lumen and not placed through stent struts. Guidewire access may obtained via contralateral, ipsilateral or retrograde approach. If a retrograde guidewire approach is used to cross the target lesion, guidewire exchange and an antegrade approach is required prior to treatment with the Winsor Laser Catheter.
- One or more patent tibial vessel(s) defined as <50% stenosis thoughout the segment with outflow to the foot.
- Successful treatment of any inflow lesion(s) defined as final residual stenosis <30%.
Who cannot join
- Patient is pregnant.
- Has known uncontrollable hypercoagulable condition, or refuses blood transfusion.
- Any co-morbid condition that in the judgment of the physician precludes safe percutaneous intervention.
- Crossing devices other than guidewire support catheters.
- Type 4 or 5 stent fracture as assessed by angiography.
- Target lesion is located within a covered stent.
- Acute limb ischemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First in Human Study of Winsor Laser Catheter
The study will evaluate the procedural safety and efficacy of the Winsor Laser Catheters for the treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)
- Conditions
- Femoropopliteal In-Stent Restenosis
- Being tested
- Winsor Laser Catheter
- Keywords
- ISR, Laser, SFA, PAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Winsor Laser CatheterDevice
| Study group | Role | What they receive |
|---|---|---|
| Winsor Laser Catheter | Experimental | Not described Receives: Device: Winsor Laser Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Freedom from Major Adverse Events (MAE) through hospital discharge:
- All-cause peri-procedural death
- Target limb amputation (above or below the ankle)
- Target limb re-intervention
- Target limb-related death
Measured: up to 48 hours
Secondary outcomes (1)
Efficacy
Procedural success defined as the percent of target lesions that achieve ≤30% residual stenosis at the completion of the procedure (laser atherectomy and any adjunctive treatment) as determined by an independent angiographic core lab.
Measured: During Interventional Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startJan 2014
- Primary completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoropopliteal In-Stent 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectranetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- Carlos Mena, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962389
- Sponsor's protocol ID
- Winsor - 001
- Status last verified
- Dec 2014
- First submitted
- 7 Oct 2013
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First in Human Study of Winsor Laser Catheter
- ClinicalTrials.gov ID
- NCT01962389
- Acronym / sponsor ID
- Winsor - 001
- Conditions
- Femoropopliteal In-Stent Restenosis
- Keywords
- ISR, Laser, SFA, PAD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Spectranetics CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Yale University
- Study start
- Jan 2014
- Primary completion
- Apr 2014 (estimated)
- First posted
- 14 Oct 2013 (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 study will evaluate the procedural safety and efficacy of the Winsor Laser Catheters for the treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Winsor Laser Catheter | Experimental | Device: Winsor Laser Catheter |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient age ≥ 18 years.
- Rutherford Category 2-4.
- Subject has been informed of the nature of the study, agrees to participate and has signed an Ethics Committee approved informed consent form.
- Documentation of significant ISR defined as >50% stenosis and >5 cm in length determined by diagnostic angiogram or duplex ultrasound.
- A previously deployed bare nitinol stent(s) in the femoropopliteal segment extending from the ostium of the SFA to 1 cm above the tibioperoneal trunk. A guidewire has successfully traversed the target treatment segment, or is able to cross using standard support catheter crossing techniques, is angiographically documented to be within true lumen and not placed through stent struts. Guidewire access may obtained via contralateral, ipsilateral or retrograde approach. If a retrograde guidewire approach is used to cross the target lesion, guidewire exchange and an antegrade approach is required prior to treatment with the Winsor Laser Catheter.
Key exclusion criteria (7 listed)
- Patient is pregnant.
- Has known uncontrollable hypercoagulable condition, or refuses blood transfusion.
- Any co-morbid condition that in the judgment of the physician precludes safe percutaneous intervention.
- Crossing devices other than guidewire support catheters.
- Type 4 or 5 stent fracture as assessed by angiography.
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 |
|---|---|---|
| Winsor Laser Catheter | Device | Winsor Laser Catheter |
Primary outcome
Primary Safety Endpoint
Time frame: up to 48 hours
Freedom from Major Adverse Events (MAE) through hospital discharge: * All-cause peri-procedural death * Target limb amputation (above or below the ankle) * Target limb re-intervention * Target limb-related death
1 secondary outcome
Efficacy
Time frame: During Interventional Procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
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Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal In-Stent Restenosis (ISR)
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.
Carlos Mena, MD principal investigator
Yale University
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 Winsor Laser Catheter in people with Femoropopliteal In-Stent Restenosis, run by Spectranetics Corporation at 1 site in Colombia.
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 7 inclusion and 7 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: withdrawn, as of the sponsor's last update on 8 Dec 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 Colombia. 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 was withdrawn before enrolling participants, so there are no results.
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?
Primary Safety Endpoint (time frame: up to 48 hours). 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 8 Dec 2014.