Peripheral Arterial DiseaseDEEPER OUSNCT03807531
A Study of the Temporary Spur Stent for the Treatment of Narrowing and Blockages in the Arteries Below the Knee
A study testing Temporary Spur Stent System in people with Peripheral Arterial Disease, run by ReFlow Medical, Inc. at 6 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the performance and safety of the Temporary Spur Stent System (TSS). The TSS is intended for use in conjunction with a commercially available drug coated balloon 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
- Peripheral Arterial Disease
- What is being tested?
- Temporary Spur Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 11 Jul 2019to 1 Jun 2027
- 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
- Subject is willing and able to provide informed consent and able to comply with the study protocol.
- Life expectancy >1 year in the investigator's opinion
- Subject is > 18 years of age.
- Subject is Rutherford class 3-5.
- Stenotic, restenotic, or occlusive lesions located in the infrapopliteal vessels, with target lesion that can be successfully crossed with a guidewire.
- Target lesion must meet lesion-specific criteria in pre-screening by angiography (pre-screening with CTA, MRA or selective angiography may be performed prior to the index procedure)
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- Target vessel(s) reconstitutes(s) at or above the medial malleolus, with the target treated segment extending no more than 10 mm beyond the medial malleolus.
- 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.
- Target lesion must begin no higher than the tibioperoneal trifurcation (popliteal arteries excluded).
- Target vessel reference diameter is measured to be between 2.0 mm to 4.5 mm in diameter, assessed by one of the following methods after successful completion of guidewire crossing of the lesion site:
- Intravascular Ultrasound (IVUS)
- Optical Coherence Tomography (OCT)
- Quantitative Vascular Angiography (QVA).
- Lesion length must be > 30 mm and < 150 mm.
- Only one limb may be enrolled per subject. Up to two vessels may be treated per subject; if required, a second modality may be used for treatment in the non-target infrapopliteal vessel. Any treatment of the non-index vessel must be performed prior to the use of the investigative device and only one artery may be treated with the investigative device
- The total treated segment is defined as the total length of artery treated with the investigational device. Target treatment length is <240 mm with a maximum segment of 150 mm separated by 30 mm of healthy tissue between treated lesions.
- Successful pre-dilatation of the target lesion as outlined in the procedure instructions, defined as resulting in stenosis <50%, without resulting flow limiting dissection (Type D or greater), thrombus, or aneurysm by angiography prior to the insertion of the investigative device.
- Iliac, SFA and popliteal inflow lesions can be treated using standard angioplasty and/or an approved stent (no atherectomy) during the index procedure or >30 days prior. Inflow lesions treated intraprocedure must be treated first, prior to consideration of treatment of infrapopliteal lesions. If pre-screening with angiography, CTA, MRA, or ultrasound has been performed <365 days prior to the procedure, intra-procedure angiography of the aorto-iliac vasculature is not required, however, the infrainguinal inflow must still be imaged using angiography during the index procedure. Inflow lesions must have a healthy vessel segment of >30 mm between the study lesion and the treated segment, defined as less than 50% stenosis without aneurysmal segments.
- Retrograde access (in the infrapopliteal arteries) is permitted for lesion crossing, however, the Temporary Spur Stent System must be deployed from antegrade access
- For subjects with bilateral disease, planned treatment of the contralateral limb must either be performed >30 days prior to the index procedure or > 14 days following the index procedure.
Who cannot join
- Subject unwilling or unlikely to comply with the appropriate follow up time for the 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 has an active infection that is not controlled at the time of the procedure, including septicemia or bacteremia.
- Subject has osteomyelitis or a heel wound.
- Planned major (above the ankle) amputation of the target limb. A planned or previous minor (transmetatarsal or digit amputation) is permitted
- Recent myocardial infarction or stroke < 90 days prior to the index procedure.
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- Heart failure with Ejection Fraction < 35%
- Impaired renal function (eGFR <25 mL/min) within 30 days of procedure and subjects on dialysis
- Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica.
- Subject receiving chronic or intravenous corticosteroid therapy.
- Inability to tolerate dual antiplatelet and oral anticoagulation therapy.
- Known allergies or sensitivities to heparin, antiplatelet, or 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 subject is currently enrolled in another investigational device or drug trial that may interfere with the endpoints of this study.
- Known allergy to nitinol or nickel.
- Prior stent(s) within the target vessel, or bypass surgery of or 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. Inflow must also be free of aneurysmal segments.
- Previous treatment failure of inflow arteries (Iliac, SFA and popliteal) which required a surgical procedure. Prior bypass above the level of the infrapopliteal arteries is permitted.
- Previous treatment of inflow lesions, if not treated during the index procedure, must have been performed >30 days prior to the index procedure.
- Previous treatment of the target vessel <30 days prior to index procedure
- Angiographic evidence of thrombus within target limb.
- Inability to obtain antegrade access in the limb from which the investigative device can be deployed.
- Extremely severe calcification classified as grade 4 as measured by the Peripheral Academic Research Consortium (PARC) score or the Peripheral Arterial Calcium Scoring System (PACSS) that, in the investigator's opinion, would not be amenable to PTA.
- Type D dissections or greater incurred during pre-dilation or CTO crossing.
- Significant (>50%) stenosis of inflow arteries or unsuccessful treatment of inflow lesions.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Germany4 sites
Klinikum Hochsauerland Klinik für Angiologie
Arnsberg
Universitats Herzzentrum Bad Krozingen
Bad Krozingen
Universitätsklinikum Leipzig
Leipzig
RoMed Klinikum Rosenheim
Rosenheim
About this study
Official title: A Non-randomized Trial of the Temporary Spur Stent System for the Treatment of Lesions Located in the Infrapopliteal Arteries Outside of the United States
The purpose of this study is to evaluate the performance and safety of the Temporary Spur Stent System (TSS). The TSS is intended for use in conjunction with a commercially available drug coated balloon in the infrapopliteal arteries for the treatment of de novo or restenotic lesions.
This study is a prospective, non-randomized, multicenter, single arm trial, with sites in New Zealand, Germany, and Switzerland.
At least two and no more than 10 sites are expected to participate, with 100 subjects enrolled (no more than 40 at a single site).
The study follow up will take place over a period of 365 days. A vessel recoil substudy will be included for a select group of subjects.
Read the detailed description
The purpose of this clinical study is to evaluate the performance and safety of the Temporary Spur Stent System (TSS) for subjects with infrapopliteal arterial disease.
The Temporary Spur Stent System is intended for use in conjunction with a commercially available drug coated balloon in the infrapopliteal arteries for the treatment of de novo or restenotic lesions.
The TSS has been developed to provide another treatment option for patients with Peripheral Arterial Disease (PAD), and Critical Limb Ischemia (CLI).
Up to 100 subjects will be treated with the Temporary Spur Stent System in conjunction with an approved Drug Coated Balloon (DCB). No less than 1 subject and no more than 40 subjects will be enrolled at a single site.
A vessel recoil substudy is included in the trial. The purpose of this study is to evaluate vessel recoil in a select group of subjects (no more than 10 per site, up to 35 subjects in total). This will be conducted by obtaining measurements using Optical Coherence Tomography (OCT), Intravascular Ultrasound (IVUS), or Quantitative Vascular Analysis (QVA) of the target vessel during the index procedure.
The statistical analysis for this trial will use as a comparator a performance goal derived from a meta-analysis of infrapopliteal balloon angioplasty. Descriptive statistics may be used to describe other data points.
Subjects will be asked to participate in a baseline evaluation visit, the index procedure, a 30 day follow up visit, a 90 day follow up visit, a 180 day follow up visit, and a 365 day follow up visit. The baseline evaluation and index procedure visits may be combined. At each follow up visit, the subject will undergo a physical exam with wound evaluation (if applicable) including pictures, a medication history and compliance review, Ankle Brachial and Toe Brachial Indices (ABI and TBI), a duplex ultrasound of the treated limb, review of symptoms, and Adverse Events (AE) assessment. Subjects may choose to withdraw from the study at any time, for any reason. If subjects choose to withdraw, they will be asked to undergo an unscheduled study visit consisting of the aforementioned procedures.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Temporary Spur Stent System
- 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.
Temporary Spur Stent SystemDevice
Also called G2-SPUR04X60, G2-SPUR03X60, G2-SPUR02x60
Participating subjects that meet inclusion and exclusion criteria will undergo treatment of infrapopliteal occlusions and stenoses with the Temporary Spur Stent System according to protocol guidelines
| Study group | Role | What they receive |
|---|---|---|
| Treatment with TSS | Other | This is a single-arm study. Participating subjects will be treated with the Temporary Spur Stent System (TSS) Receives: Device: Temporary Spur Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency of treated lesion sites by duplex ultrasound in subjects who are free from clinically driven TLR (target lesion revascularization)
The primary performance endpoint will be primary patency of treated lesion sites by duplex ultrasound in subjects who are free from clinically driven TLR (target lesion revascularization).
Measured: 6 months
Freedom from device and procedure-related death through 30 days post-procedure
The primary safety endpoint is freedom from device and procedure-related death through 30 days post-procedure
Measured: 30 days
Secondary outcomes (3)
Freedom from clinically driven target lesion revascularization through 6 months post procedure.
The secondary efficacy endpoint is freedom from clinically driven target lesion revascularization through 6 months post procedure.
Measured: 6 months
Decrease in Rutherford class score at 3, 6 and 12 months.
The second secondary efficacy measurement is decrease in Rutherford class score at 3, 6 and 12 months. Rutherford score is a classification system for patients with peripheral vascular disease.
Categories are numbered from 0 to 6, with 0 being asymptomatic, and 6 being major tissue loss, functional foot no longer salvageable. Higher values are therefore considered a worse outcome.
Rutherford class zero: No symptoms; Rutherford class 1: Mild Claudication (minimal leg pain with ambulation) symptoms; Rutherford Class 2: Moderate Claudication (moderate leg pain with ambulation); Rutherford Class 3: Severe claudication (severe leg pain with ambulation); Rutherford Class 4: Ischemic Rest pain (leg pain at rest); Rutherford Class 5: Minor tissue loss (nonhealing ulcer, focal gangrene, diffuse pedal ischemia); Rutherford class 6: Major tissue loss (extending above the transmetatarsal TM level, functional foot no longer salvageable.
Measured: 3, 6, and 12 months
Wound healing for subjects with Rutherford class 5 at 6 and 12 months, as assessed by the investigator using WIfI score and descriptive characteristics, including change in wound size measured by any decrease in wound surface area.
The third secondary efficacy endpoint is wound healing for subjects with Rutherford class 5 at 6 and 12 months, as assessed by the investigator using WIfI score and descriptive characteristics, including change in wound size measured by any decrease in wound surface area.
The WIfI classification scoring system is a grading system using a composite score of wound (W), ischemia (I), and foot infection (fi). These three different categories are graded from 0 to 3 with 0 being the best and 3 being the worst.
The total score will be provided (clinical stage 1-5), which is used to estimate the risk for major amputation at one year. Patients with a score of 1 are considered low risk, and patients with a score of 5 are considered high risk (foot not salvageable). Therefore, higher values are considered a worse outcome.
The composite score is calculated by adding up the score from each category.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start11 Jul 2019
- Primary completion30 Apr 2023
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- Multicenter, non-randomized, single-arm study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ReFlow Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinLogix. LLC
- Responsible party
- Sponsor
- Investigators
- Andrew Holden, MBChB, Principal investigator, Auckland Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807531
- Sponsor's protocol ID
- CP-002
- Acronym
- DEEPER OUS
- Status last verified
- Aug 2026
- First submitted
- 11 Jan 2019
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G; Society for Vascular Surgery Lower Extremity Guidelines Committee. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014 Jan;59(1):220-34.e1-2. doi: 10.1016/j.jvs.2013.08.003. Epub 2013 Oct 12.
PubMed 24126108
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized Trial of the Temporary Spur Stent System for the Treatment of Lesions Located in the Infrapopliteal Arteries Outside of the United States
- ClinicalTrials.gov ID
- NCT03807531
- Acronym / sponsor ID
- DEEPER OUS / CP-002
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ReFlow Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ClinLogix. LLC
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 17 Jan 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.
The purpose of this study is to evaluate the performance and safety of the Temporary Spur Stent System (TSS). The TSS is intended for use in conjunction with a commercially available drug coated balloon in the infrapopliteal arteries for the treatment of de novo or restenotic lesions.
This study is a prospective, non-randomized, multicenter, single arm trial, with sites in New Zealand, Germany, and Switzerland.
At least two and no more than 10 sites are expected to participate, with 100 subjects enrolled (no more than 40 at a single site).
The study follow up will take place over a period of 365 days. A vessel recoil substudy will be included for a select group of subjects.
Detailed description
The purpose of this clinical study is to evaluate the performance and safety of the Temporary Spur Stent System (TSS) for subjects with infrapopliteal arterial disease.
The Temporary Spur Stent System is intended for use in conjunction with a commercially available drug coated balloon in the infrapopliteal arteries for the treatment of de novo or restenotic lesions.
The TSS has been developed to provide another treatment option for patients with Peripheral Arterial Disease (PAD), and Critical Limb Ischemia (CLI).
Up to 100 subjects will be treated with the Temporary Spur Stent System in conjunction with an approved Drug Coated Balloon (DCB). No less than 1 subject and no more than 40 subjects will be enrolled at a single site.
A vessel recoil substudy is included in the trial. The purpose of this study is to evaluate vessel recoil in a select group of subjects (no more than 10 per site, up to 35 subjects in total). This will be conducted by obtaining measurements using Optical Coherence Tomography (OCT), Intravascular Ultrasound (IVUS), or Quantitative Vascular Analysis (QVA) of the target vessel during the index procedure.
The statistical analysis for this trial will use as a comparator a performance goal derived from a meta-analysis of infrapopliteal balloon angioplasty. Descriptive statistics may be used to describe other data points.
Subjects will be asked to participate in a baseline evaluation visit, the index procedure, a 30 day follow up visit, a 90 day follow up visit, a 180 day follow up visit, and a 365 day follow up visit. The baseline evaluation and index procedure visits may be combined. At each follow up visit, the subject will undergo a physical exam with wound evaluation (if applicable) including pictures, a medication history and compliance review, Ankle Brachial and Toe Brachial Indices (ABI and TBI), a duplex ultrasound of the treated limb, review of symptoms, and Adverse Events (AE) assessment. Subjects may choose to withdraw from the study at any time, for any reason. If subjects choose to withdraw, they will be asked to undergo an unscheduled study visit consisting of the aforementioned procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicenter, non-randomized, single-arm study
| Arm | Type | Receives |
|---|---|---|
| Treatment with TSS | Other | Device: Temporary Spur Stent SystemThis is a single-arm study. Participating subjects will be treated with the Temporary Spur Stent System (TSS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Subject is willing and able to provide informed consent and able to comply with the study protocol.
- Life expectancy >1 year in the investigator's opinion
- Subject is > 18 years of age.
- Subject is Rutherford class 3-5.
- Stenotic, restenotic, or occlusive lesions located in the infrapopliteal vessels, with target lesion that can be successfully crossed with a guidewire.
Key exclusion criteria (24 listed)
- Subject unwilling or unlikely to comply with the appropriate follow up time for the 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 has an active infection that is not controlled at the time of the procedure, including septicemia or bacteremia.
- Subject has osteomyelitis or a heel wound.
- Planned major (above the ankle) amputation of the target limb. A planned or previous minor (transmetatarsal or digit amputation) 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 |
|---|---|---|
| Temporary Spur Stent SystemAlso: G2-SPUR04X60, G2-SPUR03X60, G2-SPUR02x60Participating subjects that meet inclusion and exclusion criteria will undergo treatment of infrapopliteal occlusions and stenoses with the Temporary Spur Stent System according to protocol guidelines | Device | Treatment with TSS |
Primary outcome
Primary patency of treated lesion sites by duplex ultrasound in subjects who are free from clinically driven TLR (target lesion revascularization)
Time frame: 6 months
The primary performance endpoint will be primary patency of treated lesion sites by duplex ultrasound in subjects who are free from clinically driven TLR (target lesion revascularization).
Freedom from device and procedure-related death through 30 days post-procedure
Time frame: 30 days
The primary safety endpoint is freedom from device and procedure-related death through 30 days post-procedure
3 secondary outcomes
Freedom from clinically driven target lesion revascularization through 6 months post procedure.
Time frame: 6 months
Decrease in Rutherford class score at 3, 6 and 12 months.
Time frame: 3, 6, and 12 months
Wound healing for subjects with Rutherford class 5 at 6 and 12 months, as assessed by the investigator using WIfI score and descriptive characteristics, including change in wound size measured by any decrease in wound surface area.
Time frame: 6 and 12 months
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 12 Aug 2026.
- Background: PubMed 24126108Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G; Society for Vascular Surgery Lower Extremity Guidelines Committee. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014 Jan;59(1):220-34.e1-2. doi: 10.1016/j.jvs.2013.08.003. Epub 2013 Oct 12.
- 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.
Andrew Holden, MBChB principal investigator
Auckland Hospital
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary Spur Stent System in people with Peripheral Arterial Disease, run by ReFlow Medical, Inc. at 6 sites in 3 countries.
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 21 inclusion and 24 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: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, New Zealand, Switzerland. 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?
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?
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?
Primary patency of treated lesion sites by duplex ultrasound in subjects who are free from clinically driven TLR (target lesion revascularization) (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT03807531, which also lists 1 linked publication.
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 12 Aug 2026.