Peripheral Arterial DiseaseNCT04241224
A Prospective, Multicenter Atherectomy Study Showing Luminal Gain in Subjects With Peripheral Vascular Blockages
A study testing Atherectomy in people with Peripheral Arterial Disease, run by Ra Medical Systems at 10 sites in United States.
Trial summary
To evaluate the safety and effectiveness of the DABRA Laser System in the atherectomy of peripheral vascular stenoses. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Atherectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 10 sitesUnited States
- Study dates
- 26 Feb 2020to 17 Nov 2022
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability and willingness to give written informed consent and comply with follow-up requirements
- PAD with Rutherford Class 2-5
- Stenotic lesion(s) in the peripheral vasculature
- Subject is a candidate for atherectomy for infrainguinal peripheral artery disease
- Angiographic Inclusion Criteria
- Target vessel with documented stenosis by angiography ≥70% and ≤100% by angiography (as determined by Investigator)
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- Target vessel ≤ 3.0 mm in diameter
- Target Lesion ≤ 25cm in length
- The lesion to be treated is not severely calcified
- Untreated ipsilateral iliac stenosis ≤70% (or tortuosity that might prevent advancing sheath to lesion) as applicable depending on access
- No use of another atherectomy device in the same procedure
- Treatment site is not located in a graft
- Treatment site is not in, or distal to, a previously placed stent
- No flow limiting dissection proximal, distal, or in the target lesion (prior to the use of the investigational device)
- Participants meeting any of the exclusion criteria at the time of enrollment (index procedure/ intervention) will be excluded from study participation:
Who cannot join
- Age below 22 years
- Pregnant, breastfeeding, planning to become pregnant. If women of reproductive capability will be enrolled, status will be assessed via pregnancy testing. Subject must agree to use effective birth control measures for duration of study. Pregnancy during study must be reported immediately.
- Myocardial infarction (MI) ≤ 60 days prior to procedure
- Cerebrovascular Accident (CVA) ≤ 60 days prior to procedure
- Endovascular or surgical procedure ≤ 30 Days prior to procedure or a planned endovascular or surgical procedure within 30 days after the index procedure
- Disorders or allergies precluding use of radiographic contrast including renal insufficiency severe enough to contraindicate use of radiographic contrast
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- Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated
- Life expectancy ≤ 12 months
- Patient is participating in another investigational drug or device study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
MIMIT Health
Chicago, Illinois, 60616
South Texas Vascular Institute
Edinburg, Texas, 78539
California Heart & Vascular Clinic
El Centro, California, 92243
The Cardiac & Vascular Institute
Gainesville, Florida, 32605
MIMIT Health
Glen Ellyn, Illinois, 60137
Vascardio Heart and Vascular Institute
Hialeah, Florida, 33013
Texas Tech University Health Sciences Center - Center for Cardiovascular Health
Lubbock, Texas, 79430
Laser Surgical Solutions
McAllen, Texas, 78501
Merced Vein & Vascular Center
Merced, California, 95340
Eastlake Cardiovascular
Roseville, Michigan, 48066
About this study
To evaluate the safety and effectiveness of the DABRA Laser System in the atherectomy of peripheral vascular stenoses.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Atherectomy
- Keywords
- lower extremity Peripheral Arterial Disease (PAD)
- 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.
AtherectomyDevice
Also called DABRA Laser System
Endovascular treatment of peripheral arterial disease
| Study group | Role | What they receive |
|---|---|---|
| Excimer Laser Photoablation | Experimental | Device: DABRA Laser System
Patients with symptomatic peripheral vascular disease undergoing an endovascular revascularization procedure utilizing the DABRA Laser System. Receives: Device: Atherectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success
The Primary Efficacy Endpoint is the mean reduction in percent diameter stenosis in each subject's primary lesion following treatment with the DABRA Laser System and before any other treatment, as assessed by an independent Angiographic Core Laboratory.
Measured: At Index Procedure
Freedom from Major Adverse Events (MAE)
Primary safety endpoint is freedom from Major Adverse Events, defined as all-cause mortality, unplanned major target limb amputation (at or above the ankle), clinically driven target limb revascularization (CD-TLR) at 30 Days, as classified by the Clinical Events Committee (CEC).
Measured: 30 Days
Secondary outcomes (5)
Incidence of Target Lesion Revascularization (TLR) at 6 months
Clinically driven target lesion revascularization (TLR) at 6 months.
Measured: 6 months
Reduction in Residual Diameter Stenosis
Incidence of achieving a residual diameter percent stenosis of ≤ 50% in the primary lesion on the day of treatment, prior to any adjunctive therapy.
Measured: At Index Procedure
Rutherford Classification
Change from baseline in Rutherford Category.
Measured: 30 Days, 6 Months
Change in Percent Diameter Stenosis
Percent diameter stenosis and change from baseline in percent diameter stenosis as measured by Doppler Ultrasound and assessed by an independent core laboratory.
Measured: 30 Days, 6 Months
Vessel Patency
Vessel patency as measured by Doppler ultrasound and assessed by an independent core laboratory.
Measured: 30 Days, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start26 Feb 2020
- Primary completion31 May 2022
- Study completion17 Nov 2022
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ra Medical Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Athar Ansari, MD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241224
- Sponsor's protocol ID
- RMS 103
- Status last verified
- Jan 2023
- First submitted
- 22 Jan 2020
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Atherectomy Study Showing Luminal Gain in Subjects With Peripheral Vascular Blockages
- ClinicalTrials.gov ID
- NCT04241224
- Acronym / sponsor ID
- RMS 103
- Conditions
- Peripheral Arterial Disease
- Keywords
- lower extremity Peripheral Arterial Disease (PAD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Ra Medical SystemsIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 27 Jan 2020 (actual)
- 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 the safety and effectiveness of the DABRA Laser System in the atherectomy of peripheral vascular stenoses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Excimer Laser Photoablation | Experimental | Device: AtherectomyDevice: DABRA Laser System Patients with symptomatic peripheral vascular disease undergoing an endovascular revascularization procedure utilizing the DABRA Laser System. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Ability and willingness to give written informed consent and comply with follow-up requirements
- PAD with Rutherford Class 2-5
- Stenotic lesion(s) in the peripheral vasculature
- Subject is a candidate for atherectomy for infrainguinal peripheral artery disease
- Angiographic Inclusion Criteria
Key exclusion criteria (9 listed)
- Age below 22 years
- Pregnant, breastfeeding, planning to become pregnant. If women of reproductive capability will be enrolled, status will be assessed via pregnancy testing. Subject must agree to use effective birth control measures for duration of study. Pregnancy during study must be reported immediately.
- Myocardial infarction (MI) ≤ 60 days prior to procedure
- Cerebrovascular Accident (CVA) ≤ 60 days prior to procedure
- Endovascular or surgical procedure ≤ 30 Days prior to procedure or a planned endovascular or surgical procedure within 30 days after the index procedure
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 |
|---|---|---|
| AtherectomyAlso: DABRA Laser SystemEndovascular treatment of peripheral arterial disease | Device | Excimer Laser Photoablation |
Primary outcome
Technical Success
Time frame: At Index Procedure
The Primary Efficacy Endpoint is the mean reduction in percent diameter stenosis in each subject's primary lesion following treatment with the DABRA Laser System and before any other treatment, as assessed by an independent Angiographic Core Laboratory.
Freedom from Major Adverse Events (MAE)
Time frame: 30 Days
Primary safety endpoint is freedom from Major Adverse Events, defined as all-cause mortality, unplanned major target limb amputation (at or above the ankle), clinically driven target limb revascularization (CD-TLR) at 30 Days, as classified by the Clinical Events Committee (CEC).
5 secondary outcomes
Incidence of Target Lesion Revascularization (TLR) at 6 months
Time frame: 6 months
Reduction in Residual Diameter Stenosis
Time frame: At Index Procedure
Rutherford Classification
Time frame: 30 Days, 6 Months
Change in Percent Diameter Stenosis
Time frame: 30 Days, 6 Months
Vessel Patency
Time frame: 30 Days, 6 Months
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 17 Jan 2023.
- 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.
Athar Ansari, MD study chair
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atherectomy in people with Peripheral Arterial Disease, run by Ra Medical Systems at 10 sites 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 15 inclusion and 9 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 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Technical Success (time frame: At Index Procedure). 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 17 Jan 2023.