Peripheral Arterial DiseaseNCT02653456
Evaluating Plaque Photoablation Using an Excimer Laser in Patients With Lower Extremity Vascular Disease
A study testing RA-308 Excimer Laser and DABRA Catheter in people with Peripheral Arterial Disease, run by Ra Medical Systems at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of an excimer laser in the treatment of patients with lower extremity vascular disease with chronic total occlusions. 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?
- RA-308 Excimer Laser and DABRA Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Apr 2016to 14 Jul 2017
- 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
- signed informed consent
- symptomatic infrainguinal lower extremity vascular disease (Rutherford category 3, 4, 5 or 6), stable for at least 2 weeks prior to study inclusion
- lesions in the superficial femoral artery (SFA), popliteal, or infrapopliteal arteries at least one angiographically identifiable infrageniculate artery
- patients must be poor surgical candidates, indicated by at least one of the following conditions:
- absence of venous autologous grafts (that is, lack of a suitable vein to use for bypass)
- poor (diffusely diseased or <=1mm diameter) or no distal vessels available for graft anastamosis
- high risk of surgical mortality, evidenced by American Society of Anesthesiologists Physical Class 4 or higher
Who cannot join
- age below 18 years
- pregnancy, or plan to become pregnant
- participation in another cardiovascular or peripheral vascular study
- myocardial infarction (MI) in prior month
- stents at treatment site
- disorders or allergies precluding use of radiographic contrast
Show all 16Show fewer
- renal insufficiency sever enough to contraindicate use of radiographic contrast
- contraindication to treatment with anticoagulants
- untreated ipsilateral iliac stenosis >70%
- inability or unwillingness of the patient to comply with intended examinations
- unavailability of required procedural or imaging equipment
- lesion located in a graft
- hemodynamically significant arrhythmia or left ventricular ejection fraction <20%
- life expectancy less than 6 months
- necrosis necessitating major amputation
- unwillingness of the patient to be anti-coagulated
Trial locations and contacts
3 sites in 1 country.
United States3 sites
California Heart & Vascular Clinic
El Centro, California, 92243
Merit Health Wesley
Hattiesburg, Mississippi, 39402
University of California San Diego
San Diego, California, 92093
About this study
Official title: A Prospective, Multi Center Pilot Study Evaluating Plaque Photoablation Using the RA-308 Excimer Laser in Subjects With Symptomatic Infrainguinal Lower Extremity Vascular Disease
The purpose of this study is to evaluate the safety and efficacy of an excimer laser in the treatment of patients with lower extremity vascular disease with chronic total occlusions.
Read the detailed description
The study is a multi center, prospective, non-randomized, open-label study conducted at a minimum of one investigational center. 50 subjects can be enrolled. Follow-up occurs at the end of the procedure in the form of an angiogram to determine if the lesion was crossed. Additional follow-up may not necessary because of the binary nature of the crossing, and also because any future follow-up would be assessing the effectiveness of adjunct therapy, e.g. balloon angioplasty. Long term results are entirely dependent on this subsequent treatment. Because the DABRA crosser only allows adjunct devices to be used, 30-day follow-up measuring the performance of the adjunct therapy might affect the physician's choice of therapy, and compromise the patient's treatment. Therefore, 30-day follow-up, which evaluates the effectiveness of the adjunct therapy, might raise ethical concerns. However, the follow-up can be done by Ankle-Brachial Index, Doppler ultrasound, auscultation, or by discussion of the level of claudication and motion pain with the patient. To evaluate the safety and efficacy of the RA-308 Excimer Laser System and DABRA Catheter for treating subjects with symptomatic infrainguinal lower extremity vascular disease with chronic total occlusions that cannot be crossed with standard guide wires, or lesions where an attempt to cross would, in the opinion of the interventionalist, result in either a subintimal path or a perforation.
- Conditions
- Peripheral Arterial Disease
- Being tested
- RA-308 Excimer Laser and DABRA Catheter
- Keywords
- excimer laser, percutaneous catheter, photoablation, chronic total occlusion, symptomatic infrainguinal lower extremity vascular disease
- 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.
RA-308 Excimer Laser and DABRA CatheterDevice
See information already included in arm description
| Study group | Role | What they receive |
|---|---|---|
| RA-308 Excimer Laser and DABRA Catheter | Experimental | Treatment with the RA-308 excimer laser and DABRA catheter to treat chronic total occlusions that cannot be crossed with standard guidewires. The catheter and laser are a system, and cannot be used separately. Receives: Device: RA-308 Excimer Laser and DABRA Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crossing the Target Lesion
Crossing the target lesion based on angiographic analysis
Measured: at time of procedure
Secondary outcomes (3)
Number of Participants With no Device-related Major Adverse Events
Number of participants with no device-related major adverse events as determined by physician evaluation
Measured: at time of procedure, up to an hour
Number of Participants With Target Lesion Revascularization
Number of participants with target lesion revascularization as determined by physician evaluation
Measured: 30 days
Number of Participants With Target Lesion Revascularization
Number of participants with target lesion revascularization as determined by physician evaluation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study start7 Apr 2016
- Primary completion3 May 2017
- Study completion14 Jul 2017
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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ra Medical Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ehtisham Mahmud, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653456
- Sponsor's protocol ID
- RMS-102
- Status last verified
- Oct 2018
- First submitted
- 8 Jan 2016
- Last updated
- 21 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi Center Pilot Study Evaluating Plaque Photoablation Using the RA-308 Excimer Laser in Subjects With Symptomatic Infrainguinal Lower Extremity Vascular Disease
- ClinicalTrials.gov ID
- NCT02653456
- Acronym / sponsor ID
- RMS-102
- Conditions
- Peripheral Arterial Disease
- Keywords
- excimer laser, percutaneous catheter, photoablation, chronic total occlusion, symptomatic infrainguinal lower extremity vascular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ra Medical SystemsIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2016 (actual)
- Primary completion
- 3 May 2017 (actual)
- Study completion
- 14 Jul 2017 (actual)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Posted 24 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of an excimer laser in the treatment of patients with lower extremity vascular disease with chronic total occlusions.
Detailed description
The study is a multi center, prospective, non-randomized, open-label study conducted at a minimum of one investigational center. 50 subjects can be enrolled. Follow-up occurs at the end of the procedure in the form of an angiogram to determine if the lesion was crossed. Additional follow-up may not necessary because of the binary nature of the crossing, and also because any future follow-up would be assessing the effectiveness of adjunct therapy, e.g. balloon angioplasty. Long term results are entirely dependent on this subsequent treatment. Because the DABRA crosser only allows adjunct devices to be used, 30-day follow-up measuring the performance of the adjunct therapy might affect the physician's choice of therapy, and compromise the patient's treatment. Therefore, 30-day follow-up, which evaluates the effectiveness of the adjunct therapy, might raise ethical concerns. However, the follow-up can be done by Ankle-Brachial Index, Doppler ultrasound, auscultation, or by discussion of the level of claudication and motion pain with the patient. To evaluate the safety and efficacy of the RA-308 Excimer Laser System and DABRA Catheter for treating subjects with symptomatic infrainguinal lower extremity vascular disease with chronic total occlusions that cannot be crossed with standard guide wires, or lesions where an attempt to cross would, in the opinion of the interventionalist, result in either a subintimal path or a perforation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RA-308 Excimer Laser and DABRA Catheter | Experimental | Device: RA-308 Excimer Laser and DABRA CatheterTreatment with the RA-308 excimer laser and DABRA catheter to treat chronic total occlusions that cannot be crossed with standard guidewires. The catheter and laser are a system, and cannot be used separately. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- signed informed consent
- symptomatic infrainguinal lower extremity vascular disease (Rutherford category 3, 4, 5 or 6), stable for at least 2 weeks prior to study inclusion
- lesions in the superficial femoral artery (SFA), popliteal, or infrapopliteal arteries at least one angiographically identifiable infrageniculate artery
- patients must be poor surgical candidates, indicated by at least one of the following conditions:
- absence of venous autologous grafts (that is, lack of a suitable vein to use for bypass)
Key exclusion criteria (16 listed)
- age below 18 years
- pregnancy, or plan to become pregnant
- participation in another cardiovascular or peripheral vascular study
- myocardial infarction (MI) in prior month
- stents at treatment site
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 |
|---|---|---|
| RA-308 Excimer Laser and DABRA CatheterSee information already included in arm description | Device | RA-308 Excimer Laser and DABRA Catheter |
Primary outcome
Crossing the Target Lesion
Time frame: at time of procedure
Crossing the target lesion based on angiographic analysis
3 secondary outcomes
Number of Participants With no Device-related Major Adverse Events
Time frame: at time of procedure, up to an hour
Number of Participants With Target Lesion Revascularization
Time frame: 30 days
Number of Participants With Target Lesion Revascularization
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Ehtisham Mahmud principal investigator
UCSD
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RA-308 Excimer Laser and DABRA Catheter in people with Peripheral Arterial Disease, run by Ra Medical Systems at 3 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 7 inclusion and 16 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 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 24 Oct 2018). 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?
Crossing the Target Lesion (time frame: at time of 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 21 Nov 2018.