Peripheral Arterial DiseaseABLATENCT02307370
Atherectomy By Laser Ablation With Turbo-Elite
A study testing Turbo-Elite Laser Catheter in people with Peripheral Arterial Disease and Peripheral Vascular Disease, run by Spectranetics Corporation.
Trial summary
The primary objective for this study is to prove the safety and effectiveness of the Spectranetics Turbo-Elite catheter in atherectomy treatment for infrainguinal arteries with catheter to vessel sizing of at least 50%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Peripheral Vascular Disease
- What is being tested?
- Turbo-Elite Laser Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PAD with Rutherford Class 1-4
- Patient is able to walk unassisted or with non-motorized assistive devices.
- Documented PAD by ABI <0.9 or previous intervention with reoccurrence of symptoms
- Documented stenosis by duplex ≥50%
Who cannot join
- Patient is pregnant or breast feeding.
- Evidence of Acute Limb Ischemia within 7 days prior to procedure.
- CVA < 60 days prior to procedure.
- MI < 60 days prior to procedure.
- Known contraindication to aspirin, antiplatelet/anti-coagulant therapies required for procedure/follow up.
- Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
Show all 10Show fewer
- Uncontrolled hypercoagulability or history of HIT or HITTS syndrome.
- Serum creatinine ≥ 2.5 mg/dL (unless dialysis-dependent) within one day prior to procedure.
- Patient is simultaneously participating in another investigational drug or device study that will interfere with the 30 day Safety Endpoint.
- Previously identified severe calcium in the vessel.
About this study
The primary objective for this study is to prove the safety and effectiveness of the Spectranetics Turbo-Elite catheter in atherectomy treatment for infrainguinal arteries with catheter to vessel sizing of at least 50%.
- Being tested
- Turbo-Elite Laser Catheter
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turbo-Elite Laser CatheterDevice
Application of laser energy to remove blockage
| Study group | Role | What they receive |
|---|---|---|
| Turbo-Elite Atherectomy | Experimental | Not described Receives: Device: Turbo-Elite Laser Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint - Mean Reduction in Percent Stenosis
The primary efficacy endpoint target was a mean reduction in percent stenosis of greater than 20% in each study participating at the time of the procedure by Angiographic Core Lab assessment after Turbo-Elite use. A participant showing a mean reduction of 20% was considered a success for the primary efficacy endpoint.
Measured: Day 1
Primary Safety Endpoint is Freedom From Major Adverse Event (MAE)
The primary safety endpoint target was 80% of study participant with freedom from a Major Adverse Event (MAE) through 30 day follow-up. A MAE was defined as: all cause death, major amputation in the target limb, or target lesion revascularization.
Measured: 30 day follow-up
Secondary outcomes (5)
Final Procedure Residual Stenosis After All Therapy
A Final Procedure Residual Stenosis by visual assessment after all therapy will be accessed acutely during the procedure.
Measured: Day 1
Characterization of Adjunctive Therapy Use
Adjunctive therapy use will be characterized by frequencies.
Measured: Day 1
Ankle-Brachial Index (ABI) Change From Baseline to 30 Days.
ABI will be assessed at baseline and within 30 days of the procedure. The ABI is calculated ratio of the highest ankle blood pressure to the highest arm blood pressure. The ABI is a non-invasive tool for screening for Peripheral Artery Disease.
Measured: Baseline and 30 Days post-procedure
Rutherford Class (RCC) Change
Rutherford Class (RCC) will be assessed at baseline and within 30 days of the procedure. The Rutherford-Becker Clinical Categories (RCC) are a classification system of chronic limb ischemia ranging from 0 (asymptomatic; no hemodynamically significant occlusive disease) to 6 (major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable). Lower categories represent better clinical status.
Measured: Baseline and 30 days of procedure
Freedom From Target Lesion Revascularization (TLR) Through 180 Days.
Freedom from target lesion revascularization (TLR) through 180 days post procedure
Measured: Day 180 (6 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionNov 2015
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial DiseaseStudies 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectranetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307370
- Sponsor's protocol ID
- D024204
- Acronym
- ABLATE
- Status last verified
- Aug 2021
- First submitted
- 26 Nov 2014
- Last updated
- 27 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atherectomy By Laser Ablation With Turbo-Elite
- ClinicalTrials.gov ID
- NCT02307370
- Acronym / sponsor ID
- ABLATE / D024204
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Spectranetics CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2014 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Posted 27 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective for this study is to prove the safety and effectiveness of the Spectranetics Turbo-Elite catheter in atherectomy treatment for infrainguinal arteries with catheter to vessel sizing of at least 50%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Turbo-Elite Atherectomy | Experimental | Device: Turbo-Elite Laser Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- PAD with Rutherford Class 1-4
- Patient is able to walk unassisted or with non-motorized assistive devices.
- Documented PAD by ABI <0.9 or previous intervention with reoccurrence of symptoms
- Documented stenosis by duplex ≥50%
Key exclusion criteria (10 listed)
- Patient is pregnant or breast feeding.
- Evidence of Acute Limb Ischemia within 7 days prior to procedure.
- CVA < 60 days prior to procedure.
- MI < 60 days prior to procedure.
- Known contraindication to aspirin, antiplatelet/anti-coagulant therapies required for procedure/follow up.
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 |
|---|---|---|
| Turbo-Elite Laser CatheterApplication of laser energy to remove blockage | Device | Turbo-Elite Atherectomy |
Primary outcome
Primary Efficacy Endpoint - Mean Reduction in Percent Stenosis
Time frame: Day 1
The primary efficacy endpoint target was a mean reduction in percent stenosis of greater than 20% in each study participating at the time of the procedure by Angiographic Core Lab assessment after Turbo-Elite use. A participant showing a mean reduction of 20% was considered a success for the primary efficacy endpoint.
Primary Safety Endpoint is Freedom From Major Adverse Event (MAE)
Time frame: 30 day follow-up
The primary safety endpoint target was 80% of study participant with freedom from a Major Adverse Event (MAE) through 30 day follow-up. A MAE was defined as: all cause death, major amputation in the target limb, or target lesion revascularization.
5 secondary outcomes
Final Procedure Residual Stenosis After All Therapy
Time frame: Day 1
Characterization of Adjunctive Therapy Use
Time frame: Day 1
Ankle-Brachial Index (ABI) Change From Baseline to 30 Days.
Time frame: Baseline and 30 Days post-procedure
Rutherford Class (RCC) Change
Time frame: Baseline and 30 days of procedure
Freedom From Target Lesion Revascularization (TLR) Through 180 Days.
Time frame: Day 180 (6 Months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Turbo-Elite Laser Catheter in people with Peripheral Arterial Disease and Peripheral Vascular Disease, run by Spectranetics Corporation.
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 4 inclusion and 10 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 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 27 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Efficacy Endpoint - Mean Reduction in Percent Stenosis (time frame: Day 1). The study lists 2 primary outcomes in all. 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 27 Aug 2021.