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A Study of the Temporary Spur Stent for the Treatment of Narrowing and Blockages in the Arteries Below the Knee (DEEPER OUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03807531
Recruitment Status : Recruiting
First Posted : January 17, 2019
Last Update Posted : February 11, 2020
Sponsor:
Collaborator:
ClinLogix. LLC
Information provided by (Responsible Party):
ReFlow Medical, Inc.

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Temporary Spur Stent System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Multicenter, non-randomized, single-arm study
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 11, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 1, 2021

Arm Intervention/treatment
Treatment with TSS
This is a single-arm study. Participating subjects will be treated with the Temporary Spur Stent System (TSS)
Device: Temporary Spur Stent System
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
Other Name: G2-SPUR04X60, G2-SPUR03X60, G2-SPUR02x60




Primary Outcome Measures :
  1. 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).

  2. 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


Secondary Outcome Measures :
  1. Freedom from clinically driven target lesion revascularization through 6 months post procedure. [ Time Frame: 6 months ]
    The secondary efficacy endpoint is freedom from clinically driven target lesion revascularization through 6 months post procedure.

  2. Decrease in Rutherford class score at 3, 6 and 12 months. [ Time Frame: 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.


  3. 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 ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is willing and able to provide informed consent and able to comply with the study protocol.
  2. Life expectancy >1 year in the investigator's opinion
  3. Subject is > 18 years of age.
  4. Subject is Rutherford class 3-5.
  5. Stenotic, restenotic, or occlusive lesions located in the infrapopliteal vessels, with target lesion that can be successfully crossed with a guidewire.
  6. 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)
  7. 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.

  8. Target lesion must begin no higher than the tibioperoneal trifurcation (popliteal arteries excluded).
  9. 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:

    1. Intravascular Ultrasound (IVUS)
    2. Optical Coherence Tomography (OCT)
    3. Quantitative Vascular Angiography (QVA).
  10. Lesion length must be > 30 mm and < 150 mm.
  11. 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
  12. 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.
  13. 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.
  14. 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.
  15. Retrograde access (in the infrapopliteal arteries) is permitted for lesion crossing, however, the Temporary Spur Stent System must be deployed from antegrade access
  16. 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.

Exclusion Criteria:

  1. Subject unwilling or unlikely to comply with the appropriate follow up time for the duration of the study in the opinion of the investigator.
  2. Subject is pregnant or planning to become pregnant during the course of the trial.
  3. Subject has an active infection that is not controlled at the time of the procedure, including septicemia or bacteremia.
  4. Subject has osteomyelitis or a heel wound.
  5. Planned major (above the ankle) amputation of the target limb. A planned or previous minor (transmetatarsal or digit amputation) is permitted
  6. Recent myocardial infarction or stroke < 90 days prior to the index procedure.
  7. Heart failure with Ejection Fraction < 35%
  8. Impaired renal function (eGFR <25 mL/min) within 30 days of procedure and subjects on dialysis
  9. Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica.
  10. Subject receiving chronic or intravenous corticosteroid therapy.
  11. Inability to tolerate dual antiplatelet and oral anticoagulation therapy.
  12. 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.
  13. The subject is currently enrolled in another investigational device or drug trial that may interfere with the endpoints of this study.
  14. Known allergy to nitinol or nickel.
  15. Prior stent(s) within the target vessel, or bypass surgery of or within the target vessel(s)
  16. 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.
  17. 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.
  18. Previous treatment of inflow lesions, if not treated during the index procedure, must have been performed >30 days prior to the index procedure.
  19. Previous treatment of the target vessel <30 days prior to index procedure
  20. Angiographic evidence of thrombus within target limb.
  21. Inability to obtain antegrade access in the limb from which the investigative device can be deployed.
  22. 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.
  23. Type D dissections or greater incurred during pre-dilation or CTO crossing.
  24. Significant (>50%) stenosis of inflow arteries or unsuccessful treatment of inflow lesions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807531


Contacts
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Contact: Carolyn M Mascho, DNP 16168028575 cmascho@reflowmedical.com
Contact: Teo Jimenez 19494810399 tjimenez@reflowmedical.com

Locations
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Germany
Klinikum Hochsauerland Klinik für Angiologie Not yet recruiting
Arnsberg, Germany
Contact: Simone Müller    Tel: +49 02932 952-244 821      
Principal Investigator: Michael Lichtenberg, Dr. Med         
Universitats Herzzentrum Bad Krozingen Recruiting
Bad Krozingen, Germany
Contact: Verena Zähringer    +49-07633 402-2431      
Principal Investigator: Thomas Zeller, Dr. med         
Universitätsklinikum Leipzig Recruiting
Leipzig, Germany
Contact: Nadine Richter    +49-0341 - 97 18770      
Principal Investigator: Dierk Scheinert, Dr. Med         
Sub-Investigator: Andrej Schmimdt, Dr. Med         
RoMed Klinikum Rosenheim Not yet recruiting
Rosenheim, Germany
Contact: Michaela Bauer    +49 8031 365 3550      
Principal Investigator: Tepe Gunnar, Dr. Med         
New Zealand
Auckland City Hospital Recruiting
Auckland, New Zealand, 1023
Contact: Helen Senior Research Clinical Coordinator    +64 9 307 4949 ext 24756    hknight@adhb.govt.nz   
Principal Investigator: Andrew Holden, MBChB         
Switzerland
Ospedale di Lugano Civico Recruiting
Lugano, Switzerland
Contact: Jos van den Berg    +41-091-811-6111      
Principal Investigator: Jos van den Berg, MD, PhD         
Sponsors and Collaborators
ReFlow Medical, Inc.
ClinLogix. LLC
Investigators
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Principal Investigator: Andrew Holden, MBChB Auckland Hospital
Publications:
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Responsible Party: ReFlow Medical, Inc.
ClinicalTrials.gov Identifier: NCT03807531    
Other Study ID Numbers: CP-002
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases