Critical Limb IschemiaDEEPER RCTNCT06122974
Drug Eluting Temporary Spur Stent System vs Percutaneous Balloon Angioplasty for the Treatment of Critical Limb Ischemia
A study testing Drug Eluting Temporary Spur Stent System and Percutaneous Transluminal Balloon Angioplasty in people with Critical Limb Ischemia, run by ReFlow Medical, Inc..
Trial summary
The purpose of this trial is to evaluate the safety and efficacy of the Drug Eluting Temporary Spur Stent System compared to PTA. The Drug Eluting Temporary Spur Stent System is intended for use as a primary treatment in the infrapopliteal arteries for the treatment of de novo or restenotic lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- Drug Eluting Temporary Spur Stent System and Percutaneous Transluminal Balloon Angioplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 518 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Dec 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Pre-Procedure Inclusion Criteria:
- Subject willing and able to provide informed consent and able to comply with the study protocol and follow up. Subjects who are unable to sign due to a physical limitation may have a Legally Authorized Representative (LAR), including a family member, sign on their behalf.
- Life expectancy greater than 1 year in the investigator's opinion.
- Subject is greater than 18 years of age.
- Subjects must have chronic (greater than 14 days) symptoms of limb ischemia, determined by clinical symptoms of Rutherford class 4-5, rest pain (R4), and/or minor tissue loss (R5), that in the opinion of the investigator are not amenable to conservative medical therapy and require endovascular intervention for alleviation of symptoms and tissue preservation.
- For subjects with bilateral disease, planned treatment of the contralateral limb must either be performed greater than or equal to 7 days prior to the index procedure or greater than or equal to 30 days following the index procedure.
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- Angiographic Inclusion Criteria:
- Stenotic, restenotic, or occlusive lesions with greater than or equal to 70% stenosis located in the infrapopliteal vessels, with target lesion that can be successfully crossed with a guidewire via the true lumen.
- Iliac, Superficial Femoral Artery (SFA) and popliteal inflow lesions can be treated using standard of care during the index procedure
- Note:
- Inflow lesions treated intraprocedure must be treated first, prior to consideration of treatment of infrapopliteal lesions.
- Treatment of in-stent restenosis in inflow treatment is permitted, provided that stents are not severely fractured or otherwise compromised.
- Distal embolic protection is strongly encouraged in cases where atherectomy is used.
- Inflow lesions must have a healthy vessel segment of greater than 30 mm between the study lesion and the treated segment, defined as less than 50% stenosis without aneurysmal segments.
- Inflow treatment must be successful, prior to treatment of the target lesion, resulting in stenosis less than or equal to 30%, without resulting flow limiting (Type D or greater) dissection, thrombus, or aneurysm by angiography prior to randomization.
- Target vessel reconstitutes at or above the ankle, with the target treated segment ending at least 10 mm above the ankle joint.
- Note:
- If the anterior tibial or posterior tibial arteries are treated, there must be inline flow to the foot.
- If the peroneal artery is treated, there must be at least one collateral supplying the foot.
- In all cases, patent runoff (no lesions with greater than 50% stenosis) must be present via the dorsalis pedis and/or plantar arteries.
- Target lesion must be located in the tibial arteries. If vessel sizing remains appropriate, treatment may extend into the distal popliteal (P3) segment.
- Target vessel reference diameter is measured to be greater than or equal to 2.5 and less than or equal to 4.25 mm in diameter assessed by one of the following methods after successful completion of guidewire crossing of the lesion site (visual estimate permitted):
- Intravascular Ultrasound (IVUS)
- Quantitative Vascular Angiography (QVA)
- Visual Estimate
- Target lesion length must be less than or equal to 210 mm cumulatively. Tandem lesions that are less than or equal to 4 cm should be treated as one lesion. Multiple discrete lesions may be treated provided cumulative length is less than or equal to 210 mm.
- Only one limb and one vessel may be enrolled per subject. If the investigator feels that multiple infrapopliteal vessels must be treated during the index procedure, a standard practice treatment may be performed in the non-target infrapopliteal vessel(s). This should be prior to randomization of and treatment of the target vessel whenever possible.
- Note:
- Distal embolic protection is strongly recommended in cases using atherectomy.
- Treatment of the target vessel/lesion may be performed only if treatment of the non-target vessel(s)/lesion(s) does not result in a complication which may compromise the outflow of the target lesion or result in a major adverse limb event.
- Treatment of non-target lesions must be parallel to, and not contiguous with, the target lesion.
- Retrograde access (in the infrapopliteal arteries) is permitted for lesion crossing; however, the randomized treatment must be deployed from antegrade (above the knee, either ipsilateral or contralateral) access.
Who cannot join
- Pre-procedure Exclusion Criteria:
- Subject unwilling or unlikely to comply with the 5-year duration of the study in the opinion of the investigator.
- Subject is pregnant or planning to become pregnant during the course of the trial.
- Subject is breastfeeding or planning to breastfeed during the course of the trial.
- Subject has an active systemic infection that is not controlled at the time of the procedure, including septicemia or bacteremia.
- Subject has osteomyelitis proximal to the phalanges of the target foot. Osteomyelitis in the digit(s) of the target foot is permitted.
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- Wounds in the target limb must be confined to the foot below the ankle.
- Heel wounds on the target foot are excluded; wounds on the plantar surface of the hindfoot are permitted.
- Planned major (above the ankle) amputation of the target limb. A planned or previous minor (transmetatarsal amputation or digit amputation) amputation) is permitted.
- Myocardial infarction (MI) or stroke within 90 days of the index procedure.
- Symptomatic acute heart failure New York Heart Association (NYHA) class III or greater.
- Impaired renal function (estimated Glomerular Filtration Rate (eGFR) less than or equal to 25 mL/min) within 30 days of procedure or end stage renal disease on dialysis.
- Subject with vasculitis or uncontrolled clotting disorder that may preclude patient to thrombotic events.
- Inability to tolerate dual antiplatelet and/or anticoagulation therapy, including a history of severe bleeding or coagulopathy.
- Known allergies or sensitivities to heparin, antiplatelet drugs, other anticoagulant therapies which could not be substituted, drug balloon coatings and their excipients, including, but not limited to, paclitaxel, sirolimus, or zotarolimus, or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
- The subject is currently enrolled in another investigational device or drug trial that interferes with the study endpoints.
- Known allergy to nitinol or nickel.
- Bypass surgery of the target vessel. Prior bypass above the level of the infrapopliteal arteries is permitted.
- Angiographic Exclusion Criteria
- Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion. Inflow must also be free of unstable or flow limiting aneurysmal segments.
- Fractured or otherwise compromised stents or dissection repair devices in the target vessel or inflow vessel.
- In-stent restenosis in the target vessel, including restenosis of dissection repair devices.
- Previous treatment of the target vessel less than or equal to 90 days prior to index procedure.
- Angiographic evidence of thrombus within target limb.
- Extremely severe calcification that, in the investigator's opinion, would not be amenable to PTA.
- Flow-limiting dissection incurred during lesion crossing
- Significant (greater than or equal to 70%) stenosis of inflow arteries or unsuccessful treatment of inflow lesions.
- Distance from access to lesion is too long for 135 cm working length of catheter.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A RanDomized Controlled Trial of the Drug Eluting TEmporary Spur StEnt System vs PERcutaneous Balloon Angioplasty for the TReatment of CriTical Limb Ischemia
The purpose of this trial is to evaluate the safety and efficacy of the Drug Eluting Temporary Spur Stent System compared to PTA.
The Drug Eluting Temporary Spur Stent System is intended for use as a primary treatment in the infrapopliteal arteries for the treatment of de novo or restenotic lesions.
Read the detailed description
This is a randomized controlled trial evaluating the safety and efficacy of the Drug Eluting Temporary Spur Stent System (Spur) compared to percutaneous transluminal balloon angioplasty (PTA). The trial will be conducted in two phases.
Phase A is a prospective, multi-center, 1:1 randomized dual arm study of 20 subjects, evaluating the short-term safety of the Drug Eluting Temporary Spur Stent System compared to PTA to treat lesions in infrapopliteal arteries in subjects with critical limb ischemia (CLI). Thirty (30) day data from Subjects in Phase A will be evaluated by an independent Data Safety Monitoring Board (DSMB) and submitted to the Food and Drug Administration (FDA) for review. Phase A subjects will be rolled into Phase B.
Phase B is a prospective, multicenter, 1:1 randomized dual arm study of no less than 345 and up to 518 subjects, evaluating the safety and efficacy of the Drug Eluting Temporary Spur Stent System compared to PTA to treat lesions in infrapopliteal arteries in subjects with CLI.
- Conditions
- Critical Limb Ischemia
- Being tested
- Drug Eluting Temporary Spur Stent System, Percutaneous Transluminal Balloon Angioplasty
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug Eluting Temporary Spur Stent SystemDevice
The Spur Stent consists of a sirolimus coated stent and balloon that is retrievable after delivery of the sirolimus formulation.
Percutaneous Transluminal Balloon AngioplastyDevice
A balloon catheter is inserted across a lesion and inflated to fracture and compress the plaque, creating a larger lumen and improved blood flow through the artery.
| Study group | Role | What they receive |
|---|---|---|
| Study Device | Other | Subjects randomized to the Drug Eluting Temporary Spur Stent System Receives: Device: Drug Eluting Temporary Spur Stent System |
| Control | Other | Subjects randomized to the PTA Receives: Device: Percutaneous Transluminal Balloon Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase A: Primary Safety Endpoint
Freedom from the occurrence of major adverse limb events (MALE), and peri-operative death (POD), in Drug Eluting Temporary Spur Stent System and PTA-treated subjects through 30 days post-procedure. MALE are defined as:
- Major amputation above the ankle
- Major (open vascular surgery) reintervention
- Target vessel thrombectomy or thrombolysis
Measured: 30 Days
Phase B: Primary Safety Endpoint
Freedom from the occurrence of POD at 30 days, and the occurrence of MALE at 6 months.
Measured: 30 Days & 6 Months
Phase B: Primary Efficacy Endpoint
Freedom from a composite endpoint of the occurrence of limb salvage and primary patency events at 6 months, defined as:
- Clinically-driven target lesion revascularization (CD-TLR).
- Above the ankle amputation in the index limb, in the presence of a totally occluded target vessel.
- 100% total occlusion of target lesion in Spur and PTA-treated subjects.
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 posted8 Nov 2023
- Study startAug 2026 (estimated)
- Primary completionJun 2032 (estimated)
- Study completionDec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies 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
- Randomised
- Intervention model
- Sequential
- Model description
- Phase A will enroll 20 subjects and evaluate 30-day safety data Phase B will enroll 345 to 518 subjects. Subjects from Phase A will be rolled into Phase B.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 518 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ReFlow Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahmood Razavi, MD, Principal investigator, Providence Hospital St. JosephS. Jay Mathews, MD, Principal investigator, Manatee Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122974
- Sponsor's protocol ID
- CP-006
- Acronym
- DEEPER RCT
- Status last verified
- Jan 2026
- First submitted
- 3 Nov 2023
- Last updated
- 7 Jan 2026
- 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 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RanDomized Controlled Trial of the Drug Eluting TEmporary Spur StEnt System vs PERcutaneous Balloon Angioplasty for the TReatment of CriTical Limb Ischemia
- ClinicalTrials.gov ID
- NCT06122974
- Acronym / sponsor ID
- DEEPER RCT / CP-006
- Conditions
- Critical Limb Ischemia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 518 participants (estimated)
- Lead sponsor
- ReFlow Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jun 2032 (estimated)
- Study completion
- Dec 2037 (estimated)
- First posted
- 8 Nov 2023 (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.
The purpose of this trial is to evaluate the safety and efficacy of the Drug Eluting Temporary Spur Stent System compared to PTA.
The Drug Eluting Temporary Spur Stent System is intended for use as a primary treatment in the infrapopliteal arteries for the treatment of de novo or restenotic lesions.
Detailed description
This is a randomized controlled trial evaluating the safety and efficacy of the Drug Eluting Temporary Spur Stent System (Spur) compared to percutaneous transluminal balloon angioplasty (PTA). The trial will be conducted in two phases.
Phase A is a prospective, multi-center, 1:1 randomized dual arm study of 20 subjects, evaluating the short-term safety of the Drug Eluting Temporary Spur Stent System compared to PTA to treat lesions in infrapopliteal arteries in subjects with critical limb ischemia (CLI). Thirty (30) day data from Subjects in Phase A will be evaluated by an independent Data Safety Monitoring Board (DSMB) and submitted to the Food and Drug Administration (FDA) for review. Phase A subjects will be rolled into Phase B.
Phase B is a prospective, multicenter, 1:1 randomized dual arm study of no less than 345 and up to 518 subjects, evaluating the safety and efficacy of the Drug Eluting Temporary Spur Stent System compared to PTA to treat lesions in infrapopliteal arteries in subjects with CLI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Phase A will enroll 20 subjects and evaluate 30-day safety data Phase B will enroll 345 to 518 subjects. Subjects from Phase A will be rolled into Phase B.
| Arm | Type | Receives |
|---|---|---|
| Study Device | Other | Device: Drug Eluting Temporary Spur Stent SystemSubjects randomized to the Drug Eluting Temporary Spur Stent System |
| Control | Other | Device: Percutaneous Transluminal Balloon AngioplastySubjects randomized to the PTA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Subject willing and able to provide informed consent and able to comply with the study protocol and follow up. Subjects who are unable to sign due to a physical limitation may have a Legally Authorized Representative (LAR), including a family member, sign on their behalf.
- Life expectancy greater than 1 year in the investigator's opinion.
- Subject is greater than 18 years of age.
- Subjects must have chronic (greater than 14 days) symptoms of limb ischemia, determined by clinical symptoms of Rutherford class 4-5, rest pain (R4), and/or minor tissue loss (R5), that in the opinion of the investigator are not amenable to conservative medical therapy and require endovascular intervention for alleviation of symptoms and tissue preservation.
- For subjects with bilateral disease, planned treatment of the contralateral limb must either be performed greater than or equal to 7 days prior to the index procedure or greater than or equal to 30 days following the index procedure.
Key exclusion criteria (28 listed)
- Subject unwilling or unlikely to comply with the 5-year duration of the study in the opinion of the investigator.
- Subject is pregnant or planning to become pregnant during the course of the trial.
- Subject is breastfeeding or planning to breastfeed during the course of the trial.
- Subject has an active systemic infection that is not controlled at the time of the procedure, including septicemia or bacteremia.
- Subject has osteomyelitis proximal to the phalanges of the target foot. Osteomyelitis in the digit(s) of the target foot is permitted.
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 |
|---|---|---|
| Drug Eluting Temporary Spur Stent SystemThe Spur Stent consists of a sirolimus coated stent and balloon that is retrievable after delivery of the sirolimus formulation. | Device | Study Device |
| Percutaneous Transluminal Balloon AngioplastyA balloon catheter is inserted across a lesion and inflated to fracture and compress the plaque, creating a larger lumen and improved blood flow through the artery. | Device | Control |
Primary outcome
Phase A: Primary Safety Endpoint
Time frame: 30 Days
Freedom from the occurrence of major adverse limb events (MALE), and peri-operative death (POD), in Drug Eluting Temporary Spur Stent System and PTA-treated subjects through 30 days post-procedure. MALE are defined as: * Major amputation above the ankle * Major (open vascular surgery) reintervention * Target vessel thrombectomy or thrombolysis
Phase B: Primary Safety Endpoint
Time frame: 30 Days & 6 Months
Freedom from the occurrence of POD at 30 days, and the occurrence of MALE at 6 months.
Phase B: Primary Efficacy Endpoint
Time frame: 6 Months
Freedom from a composite endpoint of the occurrence of limb salvage and primary patency events at 6 months, defined as: * Clinically-driven target lesion revascularization (CD-TLR). * Above the ankle amputation in the index limb, in the presence of a totally occluded target vessel. * 100% total occlusion of target lesion in Spur and PTA-treated subjects.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- 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.
Mahmood Razavi, MD principal investigator
Providence Hospital St. Joseph
S. Jay Mathews, MD principal investigator
Manatee Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Drug Eluting Temporary Spur Stent System and Percutaneous Transluminal Balloon Angioplasty in people with Critical Limb Ischemia, run by ReFlow Medical, Inc..
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 32 inclusion and 28 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: opening soon, as of the sponsor's last update on 7 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolyn Mascho, BSN, DNP, AG-NP (616-802-8575, cmascho@reflowmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase A: Primary Safety Endpoint (time frame: 30 Days). The study lists 3 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 7 Jan 2026.