Peripheral Artery DiseaseRESULTSNCT04010045
REvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study
An observational study of Peripheral Artery Disease, run by Ra Medical Systems at 1 site in United States.
Trial summary
This is an observational study of the DABRA Laser System and other medical devices intended for endovascular treatment of peripheral artery disease. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Endovascular Treatment of PAD
- Type of treatment
- Medical device
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2019to 15 Oct 2020
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population for this study is patients presenting with symptoms of peripheral artery disease.
Who may be able to join
- Participant's age ≥ 22 years.
- Participant presents with a Rutherford category of 2 to 6.
- Participant has at least one peripheral lesion, ≤ 140mm, in a native vessel that is treated successfully with DABRA Laser System.
- Participant is able and willing to be anti-coagulated.
- Ability and willingness of participant to give written informed consent and comply with follow-up.
Who cannot join
- 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.
- Endovascular interventions within 90 days prior to study enrollment (on leg to be treated).
- Participation in another cardiovascular or peripheral vascular study that might, in the judgement of the Investigator, affect the results of the study.
- Disorders or allergies precluding use of radiographic contrast including renal insufficiency severe enough to contraindicate use of radiographic contrast.
- Inability or unwillingness of the patient to comply with study examinations.
- Necrosis necessitating major amputation.
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- Subject has an anticipated life span of less than one (1) year.
- Medically non-compliant subjects, based on Investigator judgment (e.g., subject is non-compliant in following medical advice regarding blood pressure medication, cholesterol medication, and/or maintenance of healthy blood sugar levels).
- No run-off vessel is present when treating above the knee. A run-off vessel is required when treating above the knee, however, it is not required when treating below the knee.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study (RESULTS)
This is an observational study of the DABRA Laser System and other medical devices intended for endovascular treatment of peripheral artery disease.
Read the detailed description
This is an observational, prospective, consecutively enrolled, single-arm, multi-site registry of the use of the DABRA Laser System and other medical devices intended for endovascular treatment of peripheral artery disease.
This study covers the use of endovascular devices including the DABRA Laser System and other devices commercially used in the United States for the treatment of lower extremity PAD.
- Conditions
- Peripheral Artery Disease
- Being tested
- Endovascular Treatment of PAD
- Keywords
- lower extremity 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.
Endovascular Treatment of PADDevice
Also called PAD endovascular treatment using the DABRA Laser System
PAD endovascular treatment using the DABRA Laser System + other FDA cleared/ approved devices for the treatment of PAD.
What is being measured
The primary outcome is the main question the study is designed to answer.
Vessel Patency
Patency of the target lesion at 24 months, as determined by duplex ultrasound.
Measured: 24 months
Secondary outcomes (2)
Serious Adverse Events
Tabulation of serious adverse events at 1 day, 6 months, 12 months, 18 months, and 24 months
Measured: 1 day, 6 months, 12 months, 18 months, and 24 months
Vessel Patency
Patency of the target lesion at 6 months, 12 months, and 18 months, as determined by duplex ultrasound.
Measured: 6 months, 12 months, and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start2 May 2019
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
Why it stopped: Sponsor stopped the study for business reasons as site recruitment and subject enrollment have not met expectations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ra Medical Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jami Miller, Study director, Ra Medical Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010045
- Sponsor's protocol ID
- RMS-104
- Acronym
- RESULTS
- Status last verified
- Oct 2021
- First submitted
- 4 Jun 2019
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study (RESULTS)
- ClinicalTrials.gov ID
- NCT04010045
- Acronym / sponsor ID
- RESULTS / RMS-104
- Conditions
- Peripheral Artery Disease
- Keywords
- lower extremity PAD
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor stopped the study for business reasons as site recruitment and subject enrollment have not met expectations.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Ra Medical SystemsIndustry (pharma, biotech, devices)
- Study start
- 2 May 2019 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 8 Jul 2019 (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.
This is an observational study of the DABRA Laser System and other medical devices intended for endovascular treatment of peripheral artery disease.
Detailed description
This is an observational, prospective, consecutively enrolled, single-arm, multi-site registry of the use of the DABRA Laser System and other medical devices intended for endovascular treatment of peripheral artery disease.
This study covers the use of endovascular devices including the DABRA Laser System and other devices commercially used in the United States for the treatment of lower extremity PAD.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population for this study is patients presenting with symptoms of peripheral artery disease.
Key inclusion criteria (5 listed)
- Participant's age ≥ 22 years.
- Participant presents with a Rutherford category of 2 to 6.
- Participant has at least one peripheral lesion, ≤ 140mm, in a native vessel that is treated successfully with DABRA Laser System.
- Participant is able and willing to be anti-coagulated.
- Ability and willingness of participant to give written informed consent and comply with follow-up.
Key exclusion criteria (9 listed)
- 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.
- Endovascular interventions within 90 days prior to study enrollment (on leg to be treated).
- Participation in another cardiovascular or peripheral vascular study that might, in the judgement of the Investigator, affect the results of the study.
- Disorders or allergies precluding use of radiographic contrast including renal insufficiency severe enough to contraindicate use of radiographic contrast.
- Inability or unwillingness of the patient to comply with study examinations.
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 |
|---|---|---|
| Endovascular Treatment of PADAlso: PAD endovascular treatment using the DABRA Laser SystemPAD endovascular treatment using the DABRA Laser System + other FDA cleared/ approved devices for the treatment of PAD. | Device | – |
Primary outcome
Vessel Patency
Time frame: 24 months
Patency of the target lesion at 24 months, as determined by duplex ultrasound.
2 secondary outcomes
Serious Adverse Events
Time frame: 1 day, 6 months, 12 months, 18 months, and 24 months
Vessel Patency
Time frame: 6 months, 12 months, and 18 months
Results and safety
The study was stopped early (reason given: Sponsor stopped the study for business reasons as site recruitment and subject enrollment have not met expectations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- 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.
Jami Miller study director
Ra Medical Systems
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 Artery Disease, run by Ra Medical Systems 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 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: stopped early, as of the sponsor's last update on 3 Nov 2021. 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: Sponsor stopped the study for business reasons as site recruitment and subject enrollment have not met expectations.). 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?
Vessel Patency (time frame: 24 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 3 Nov 2021.