Peripheral Arterial DiseaseREXNCT02921542
An Evaluation of a Clinical Algorithm With Turbo-Power Following Treatment of Specific Morphologies
An observational study of Peripheral Arterial Disease, run by Spectranetics Corporation at 1 site in United States.
Trial summary
To evaluate vessel lumen quality (gain) and patient outcomes based on treatment with a predetermined laser treatment protocol in patients presenting with varying lesion types or morphologies: homogenous (plaques with a uniform texture-smooth and regular), heterogeneous (plaques with non-uniform texture-smooth and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Laser Atherectomy
- Type of treatment
- Medical device
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2016to 1 May 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with homogenous, heterogeneous, calcific, or restenotic with above the knee lesions eligible for treatment with laser atherectomy with Turbo-Power (target will be 15 patients enrolled in each category by lesions morphology).
Who may be able to join
- Patient age at least 18 years.
- Patient has been informed of the nature of the study, agrees to participate and has signed an approved consent form.
- Rutherford category 1, 2, 3, or 4
- Subject Patient presents with clinical evidence of PAD requiring endovascular intervention.
- Target lesion access must use the femoral approach that will accommodate at least a 7Fr sheath.
- Angiographic evidence of significant restenosis (≥ 50% by visual estimate).
Who cannot join
- Inability to obtain informed consent.
- Life expectancy < 12 months.
- Pregnancy, suspected pregnancy, or breastfeeding during study period. (Patients of childbearing potential must have negative serum pregnancy test 7 days prior to treatment.
- Any evidence of hemodynamic instability prior to procedure/randomization
- Coagulopathy or clotting disorders.
- Present or suspected systemic infection or osteomyelitis affecting target limb.
- Contraindication to contrast media or any study-required medication (antiplatelets, anticoagulants, thrombolytic, etc).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REX - A Pilot Evaluation of a Clinical Algorithm With Turbo-Power Following Treatment of Specific Morphologies
To evaluate vessel lumen quality (gain) and patient outcomes based on treatment with a predetermined laser treatment protocol in patients presenting with varying lesion types or morphologies: homogenous (plaques with a uniform texture-smooth and regular), heterogeneous (plaques with non-uniform texture-smooth and irregular surface), calcific (consisting of calcium) and restenotic (reoccurring narrowing of the vessel following prior treatment) associated with peripheral arterial disease (PAD).
Read the detailed description
Purpose: To evaluate vessel lumen quality (gain) and patient outcomes based on treatment with a predetermined laser treatment protocol in patients presenting with varying lesion types or morphologies: homogenous (plaques with a uniform texture-smooth and regular), heterogeneous (plaques with non-uniform texture-smooth and irregular surface), calcific (consisting of calcium) and restenotic (reoccurring narrowing of the vessel following prior treatment) associated with peripheral arterial disease (PAD).
Participants: 60 patients with PAD undergoing a revascularization procedure (treatment of a narrowed blood vessel) involving above the knee (ATK) lesion(s) eligible for treatment with laser atherectomy (a option for treatment of blocked blood vessels.)
Procedures (methods): Patients' qualifying lesions will be assessed with angiography (a test that uses a special dye and camera to take pictures of the blood flow in an artery) and intravascular ultrasound (IVUS) and categorized (homogenous, heterogeneous, calcific or restenotic) and determined to be treatable with laser atherectomy per standard of care. Qualified patients will undergo standard of care treatment with the Spectranetics Turbo-Power laser catheter for three passes with increasing settings 'low' (40/60), 'medium' (50/40) and 'high'(60/60), respectively. After each pass, assessments of lumen quality and residual stenosis (narrowing still present after treatment) will be determined by angiogram and IVUS. The operator may finish the procedure per standard of care/investigator discretion after the protocol defined laser passes are completed.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Laser Atherectomy
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser AtherectomyDevice
The Turbo-Power is laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents with adjunctive percutaneous transluminal angioplasty (PTA).
| Study group | Role | What they receive |
|---|---|---|
| Homogenous Lesions | Not described Receives: Device: Laser Atherectomy | |
| Heterogenous Lesions | Not described Receives: Device: Laser Atherectomy | |
| Calcific Lesions | Not described Receives: Device: Laser Atherectomy | |
| Restenotic Lesions | Not described Receives: Device: Laser Atherectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of stenosis
- Final reduction of stenosis post procedure, determined by angiogram and intravascular ultrasound (IVUS).
Measured: immediately post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study start15 Aug 2016
- Primary completion15 May 2018
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectranetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Adams, MD, Principal investigator, UNC Hospitals - REX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921542
- Sponsor's protocol ID
- 16-0393
- Acronym
- REX
- Status last verified
- Jul 2019
- First submitted
- 29 Sep 2016
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REX - A Pilot Evaluation of a Clinical Algorithm With Turbo-Power Following Treatment of Specific Morphologies
- ClinicalTrials.gov ID
- NCT02921542
- Acronym / sponsor ID
- REX / 16-0393
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Spectranetics CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2016 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 3 Oct 2016 (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.
To evaluate vessel lumen quality (gain) and patient outcomes based on treatment with a predetermined laser treatment protocol in patients presenting with varying lesion types or morphologies: homogenous (plaques with a uniform texture-smooth and regular), heterogeneous (plaques with non-uniform texture-smooth and irregular surface), calcific (consisting of calcium) and restenotic (reoccurring narrowing of the vessel following prior treatment) associated with peripheral arterial disease (PAD).
Detailed description
Purpose: To evaluate vessel lumen quality (gain) and patient outcomes based on treatment with a predetermined laser treatment protocol in patients presenting with varying lesion types or morphologies: homogenous (plaques with a uniform texture-smooth and regular), heterogeneous (plaques with non-uniform texture-smooth and irregular surface), calcific (consisting of calcium) and restenotic (reoccurring narrowing of the vessel following prior treatment) associated with peripheral arterial disease (PAD).
Participants: 60 patients with PAD undergoing a revascularization procedure (treatment of a narrowed blood vessel) involving above the knee (ATK) lesion(s) eligible for treatment with laser atherectomy (a option for treatment of blocked blood vessels.)
Procedures (methods): Patients' qualifying lesions will be assessed with angiography (a test that uses a special dye and camera to take pictures of the blood flow in an artery) and intravascular ultrasound (IVUS) and categorized (homogenous, heterogeneous, calcific or restenotic) and determined to be treatable with laser atherectomy per standard of care. Qualified patients will undergo standard of care treatment with the Spectranetics Turbo-Power laser catheter for three passes with increasing settings 'low' (40/60), 'medium' (50/40) and 'high'(60/60), respectively. After each pass, assessments of lumen quality and residual stenosis (narrowing still present after treatment) will be determined by angiogram and IVUS. The operator may finish the procedure per standard of care/investigator discretion after the protocol defined laser passes are completed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Homogenous Lesions | – | Device: Laser Atherectomy |
| Heterogenous Lesions | – | Device: Laser Atherectomy |
| Calcific Lesions | – | Device: Laser Atherectomy |
| Restenotic Lesions | – | Device: Laser Atherectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with homogenous, heterogeneous, calcific, or restenotic with above the knee lesions eligible for treatment with laser atherectomy with Turbo-Power (target will be 15 patients enrolled in each category by lesions morphology).
Key inclusion criteria (6 listed)
- Patient age at least 18 years.
- Patient has been informed of the nature of the study, agrees to participate and has signed an approved consent form.
- Rutherford category 1, 2, 3, or 4
- Subject Patient presents with clinical evidence of PAD requiring endovascular intervention.
- Target lesion access must use the femoral approach that will accommodate at least a 7Fr sheath.
Key exclusion criteria (7 listed)
- Inability to obtain informed consent.
- Life expectancy < 12 months.
- Pregnancy, suspected pregnancy, or breastfeeding during study period. (Patients of childbearing potential must have negative serum pregnancy test 7 days prior to treatment.
- Any evidence of hemodynamic instability prior to procedure/randomization
- Coagulopathy or clotting disorders.
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 |
|---|---|---|
| Laser AtherectomyThe Turbo-Power is laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents with adjunctive percutaneous transluminal angioplasty (PTA). | Device | Calcific Lesions, Heterogenous Lesions, Homogenous Lesions, Restenotic Lesions |
Primary outcome
Reduction of stenosis
Time frame: immediately post-procedure
1. Final reduction of stenosis post procedure, determined by angiogram and intravascular ultrasound (IVUS).
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 Jul 2019.
- Individual participant dataSharing planned: No
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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.
George Adams, MD principal investigator
UNC Hospitals - REX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Spectranetics Corporation 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 6 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: finished, as of the sponsor's last update on 18 Jul 2019. 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 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?
Reduction of stenosis (time frame: immediately post-procedure). 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 Jul 2019.