Critical Limb IschemiaDEEPERNCT03669458
Feasibility Clinical Trial Using the SPUR System to Demonstrate Safety and Efficacy.
A study testing Below the Knee peripheral intervention in people with Critical Limb Ischemia, run by ReFlow Medical, Inc. at 1 site in Dominican Republic.
Trial summary
To evaluate the safety and effectiveness of the Spur System in a patient population with infrapopliteal artery disease (tibioperoneal, anterior/posterior tibial and peritoneal arteries) when used in conjunction with substance/drug coated balloons. 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?
- Below the Knee peripheral intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteDominican Republic
- Study dates
- 6 Oct 2017to 4 Jun 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is willing and able to provide informed consent and able to comply with the study protocol.
- Peripheral arterial disease that can be treated using PTA.
- Life expectancy >1 year in the investigator's opinion
- Male or non-pregnant female > 18 years of age
- Patent inflow artery
- Target vessel(s) reconstitutes(s) at or above the ankle, excluding the dorsalis pedis and the calcaneal branch of the posterior tibial artery
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- Target lesion starts at or below 3 cm below the tibial plateau as measured by angiography
- Target vessel for Spur device is ≥ 3.5 mm (4mm); ≥ 2.5 mm (3mm) in diameter by visual estimate.
- Lesion(s) must be able to be treated with a minimum of one Spur or PTA or DCB product.
- Infrapopliteal lesion(s) that are located in either the left or right leg Infrapopliteal artery(s) may be treated with only one modality per artery: DCB, Spur or Spur/DCB.
- Arterial length/diameter and quantity must be able to be treated with DCB or Spur or Spur/DCB
- The treated segment is defined as the total length of artery treated with PTA.
- The cumulative treated segment of infrapopliteal artery(s) must be ≤34.0 cm.
- Lesions in the treated segment may be continuous or may have gaps present between stenosis or occlusions
- Patient has Rutherford Classification of 3-5.
- Successful pre-dilatation of the target lesion.
- Iliac, SFA and popliteal inflow lesions can be treated during the same procedure using standard angioplasty and/or approved device. These inflow lesions must be treated first, prior to consideration of treatment of infrapopliteal lesions.
- The patient can be enrolled if the inflow lesions have acceptable angiographic results (must have <30% residual stenosis and no evidence of embolization or flow limiting dissection)
Who cannot join
- Subject unwilling or unlikely to comply with the appropriate follow up time for the duration of the study
- Prior stent(s) or bypass surgery within the target vessel(s)
- Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion.
- Previous treatment failure of inflow arteries (Iliac, SFA and popliteal) which required a surgical procedure.
- Previous PTA of the target vessel within 30 day prior to index procedure
- Angiographic evidence of thrombus within target limb.
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- Subject has an active infection of the foot, including pus or wet gangrene that is not controlled at the time of the procedure.
- Planned major (above the ankle) amputation of the target limb
- Recent MI or stroke < 30 days prior to the index procedure.
- Heart failure with Ejection Fraction < 30%
- Impaired renal function (GFR <30 mL/min) and patients on dialysis
- Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica.
- Patient receiving systemic corticosteroid therapy.
- Inability to tolerate concomitant antiplatelet and oral anticoagulation therapy.
- Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant therapies which could not be substituted, and/or paclitaxel or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
- The patient is currently enrolled in another investigational device or drug trial that is interfering with the endpoints of this study.
Trial locations and contacts
1 site in 1 country.
Dominican Republic1 site
Instituto Nacional de la Diabetes (INDEN)
Santo Domingo
About this study
Official title: A Non-RandomizeD FEasibility Trial of the Spur SystEm for the Treatment of Lesions in the InfraPoplitEal ArteRy
To evaluate the safety and effectiveness of the Spur System in a patient population with infrapopliteal artery disease (tibioperoneal, anterior/posterior tibial and peritoneal arteries) when used in conjunction with substance/drug coated balloons.
Read the detailed description
The objective of this study is to perform a prospective, multi-center (min 2 sites), non-randomized study to evaluate the safety and efficacy of the Spur system and compare treatments arms (if applicable) in treating subjects with infrapopliteal disease who are at risk for amputation.
The study protocol will ensure consistency in performing the procedure, patient management and results of the procedure. Safety and efficacy will be evaluated during index procedure through one (1) year follow up
- Conditions
- Critical Limb Ischemia
- Being tested
- Below the Knee peripheral intervention
- 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.
Below the Knee peripheral interventionDevice
Also called DCB Treatment, SPUR with DCB treatment
Treatment of infrapopliteal disease using SPUR/DCB, SPUR only and DCB alone
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: BTK intervention with SPUR/DCB | Experimental | Below the knee peripheral intervention using SPUR/DCB. Receives: Device: Below the Knee peripheral intervention |
| Arm 2: BTK intervention using SPUR Only | Experimental | Below the knee peripheral intervention using SPUR only. Receives: Device: Below the Knee peripheral intervention |
| ARM 3: BTK intervention using DCB Only | Experimental | Below the knee peripheral intervention using DCB only. Receives: Device: Below the Knee peripheral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate binary arterial flow at 6 months
The primary effectiveness endpoint assess arterial flow using duplex ultrasound at 6 months post procedure.
Measured: 6 months
Secondary outcomes (2)
MALE
The secondary safety endpoint assess Freedom from Major Adverse Limb events (MALE) at 30 days
Measured: 30 days
All cause perioperative death (30 days)
The secondary safety endpoint assess all-cause perioperative death (POD) at 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start6 Oct 2017
- Primary completion4 Jun 2019
- Study completion4 Jun 2019
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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A minimum of 10 patients will be enrolled for treatment of BTK disease
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- ReFlow Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syntropic Corelab, Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Jihad Mustapha, MD, Principal investigator, Advanced Cardiac & Vascular Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03669458
- Sponsor's protocol ID
- CP-001
- Acronym
- DEEPER
- Status last verified
- Aug 2020
- First submitted
- 29 Aug 2018
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: All data need to be analyzed
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-RandomizeD FEasibility Trial of the Spur SystEm for the Treatment of Lesions in the InfraPoplitEal ArteRy
- ClinicalTrials.gov ID
- NCT03669458
- Acronym / sponsor ID
- DEEPER / CP-001
- Conditions
- Critical Limb Ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- ReFlow Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syntropic Corelab, Massachusetts General Hospital
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 4 Jun 2019 (actual)
- Study completion
- 4 Jun 2019 (actual)
- First posted
- 13 Sep 2018 (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 Spur System in a patient population with infrapopliteal artery disease (tibioperoneal, anterior/posterior tibial and peritoneal arteries) when used in conjunction with substance/drug coated balloons.
Detailed description
The objective of this study is to perform a prospective, multi-center (min 2 sites), non-randomized study to evaluate the safety and efficacy of the Spur system and compare treatments arms (if applicable) in treating subjects with infrapopliteal disease who are at risk for amputation.
The study protocol will ensure consistency in performing the procedure, patient management and results of the procedure. Safety and efficacy will be evaluated during index procedure through one (1) year follow up
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A minimum of 10 patients will be enrolled for treatment of BTK disease
| Arm | Type | Receives |
|---|---|---|
| Arm 1: BTK intervention with SPUR/DCB | Experimental | Device: Below the Knee peripheral interventionBelow the knee peripheral intervention using SPUR/DCB. |
| Arm 2: BTK intervention using SPUR Only | Experimental | Device: Below the Knee peripheral interventionBelow the knee peripheral intervention using SPUR only. |
| ARM 3: BTK intervention using DCB Only | Experimental | Device: Below the Knee peripheral interventionBelow the knee peripheral intervention using DCB only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patient is willing and able to provide informed consent and able to comply with the study protocol.
- Peripheral arterial disease that can be treated using PTA.
- Life expectancy >1 year in the investigator's opinion
- Male or non-pregnant female > 18 years of age
- Patent inflow artery
Key exclusion criteria (16 listed)
- Subject unwilling or unlikely to comply with the appropriate follow up time for the duration of the study
- Prior stent(s) or bypass surgery within the target vessel(s)
- Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion.
- Previous treatment failure of inflow arteries (Iliac, SFA and popliteal) which required a surgical procedure.
- Previous PTA of the target vessel within 30 day prior to 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 |
|---|---|---|
| Below the Knee peripheral interventionAlso: DCB Treatment, SPUR with DCB treatmentTreatment of infrapopliteal disease using SPUR/DCB, SPUR only and DCB alone | Device | ARM 3: BTK intervention using DCB Only, Arm 1: BTK intervention with SPUR/DCB, Arm 2: BTK intervention using SPUR Only |
Primary outcome
Demonstrate binary arterial flow at 6 months
Time frame: 6 months
The primary effectiveness endpoint assess arterial flow using duplex ultrasound at 6 months post procedure.
2 secondary outcomes
MALE
Time frame: 30 days
All cause perioperative death (30 days)
Time frame: 30 days
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 20 Aug 2020.
- Individual participant dataSharing planned: No. All data need to be analyzed
Related trials for Critical Limb Ischemia
Active, not recruitingObservational study
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Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
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Vessel Recoil in Specific CLTI Populations
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DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
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Nutrition in Patient With Critical Limb Ischemia
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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.
Jihad Mustapha, MD principal investigator
Advanced Cardiac & Vascular Centers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Below the Knee peripheral intervention in people with Critical Limb Ischemia, run by ReFlow Medical, Inc. at 1 site in Dominican Republic.
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 18 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 20 Aug 2020. 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 Dominican Republic. 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?
Demonstrate binary arterial flow at 6 months (time frame: 6 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 20 Aug 2020.