AzTrials
AzTrials

Peripheral Arterial DiseaseDEEPER LIMUSNCT04162418

A Study of the TEmporary Spur StEnt System for the Treatment of Lesions Located in the InfraPoplitEal ARteries Using a LIMUS-base DCB

A study testing Temporary Spur Stent System in people with Peripheral Arterial Disease and Critical Limb Ischemia, run by ReFlow Medical, Inc. at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a non-randomized, prospective, single center pilot study designed to evaluate the safety of the Temporary Spur Stent System to treat patients with infrapopliteal arterial disease, when used in conjunction with a commercially available limus-base drug coated balloon. Read more about this study

Who is it for?
Ages 18 years and older
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
26 participants
Where
1 siteAustria
Study dates
14 Feb 2020to 30 Sep 2023
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

  • 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.
  • Subjects must have symptoms of limb ischemia, determined by clinical symptoms of Rutherford class 3-5, including severe, life-limiting claudication (R 3), rest pain (R 4), 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
  • 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 at time of procedure (prescreening with CTA, MRA or selective angiography may be performed prior to the index procedure).
Show all 22Show fewer
  • Target vessel(s) reconstitute(s) at or above the ankle, with the target treated segment extending no more than 10 mm beyond the ankle.
  • 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 tibial trifurcation (popliteal artery 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 < 200 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 treated segment is defined as the total length of artery treated with the investigational device. Target treatment length is <250 mm with a maximum segment of 200 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 (Type D or greater) dissection, 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 drug coated balloon 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 duplex ultrasound, angiography, CTA, or MRA has been performed < 365 days prior to the procedure, intra-procedure angiography of the aorto-iliac vasculature is not required, however, the femoropopliteal 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 proximal to the phalanges. Osteomyelitis in the digit(s) of the target foot is permitted.
  • Subject has a heel wound, unless osteomyelitis has been ruled out with MRI, MRA, or nuclear medicine bone scan
  • Planned major (above the ankle) amputation of the target limb. A planned or previous minor (transmetatarsal amputation or digit amputation) is permitted
Show all 25Show fewer
  • Recent myocardial infarction or stroke < 90 days prior to the index procedure.
  • Symptomatic acute heart failure NYHA class III or greater.
  • Impaired renal function (eGFR <25 mL/min) within 30 days of procedure or end stage renal disease on dialysis
  • Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica.
  • Subject receiving chronic or intravenous corticosteroid therapy.
  • Inability to tolerate dual antiplatelet and/or anticoagulation therapy.
  • 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.
  • 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 (see Appendix I for definitions).
  • Type D dissections or greater incurred during predilation or CTO crossing (see Appendix I for definitions).
  • Significant (>50%) stenosis of inflow arteries or unsuccessful treatment of inflow lesions.

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Univ.-Klinikum LKH Graz

    Graz, 8036

Other trials in Austria

About this study

Official title: A Non-RanDomized Pilot Study of the TEmporary Spur StEnt System for the Treatment of Lesions Located in the InfraPoplitEal ARteries Using a LIMUS-base Drug-coated Balloon (DEEPER LIMUS)

This is a non-randomized, prospective, single center pilot study designed to evaluate the safety of the Temporary Spur Stent System to treat patients with infrapopliteal arterial disease, when used in conjunction with a commercially available limus-base drug coated balloon.

Being tested
Temporary Spur Stent System
Keywords
peripheral arterial disease, critical limb ischemia, infrapopliteal disease
Medical subject headings
Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Temporary Spur Stent SystemDevice

    Treatment of qualifying infrapopliteal lesions with Temporary Spur Stent System and a commercially available, limus-base drug-coated balloon

Study groups in NCT04162418
Study groupRoleWhat they receive
InterventionOtherTreatment with Temporary Spur Stent System and a commercially available, limus-base, drug coated balloon
Receives: Device: Temporary Spur Stent System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of All-Cause Mortality, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR) at 6 months

    6 month composite of All-Cause Mortality, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR)

    Measured: 6 months

Secondary outcomes (4)

  1. Secondary Efficacy: Late lumen loss

    Late Lumen Loss (LLL) of the target lesion by angiogram/QVA at 6 months

    Measured: 6 months

  2. Secondary Efficacy: Primary Patency

    1. Primary patency (flow/no flow) of treated lesion sites by angiogram/QVA in subjects who are free from CD-TLR at 6 months.

    Measured: 6 months

  3. Secondary Efficacy: Rutherford class

    The second secondary efficacy measurement is change 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: 12 months

  4. Secpndary Efficacy: Wound healing

    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: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2019
  2. Study start14 Feb 2020
  3. Primary completion30 Jun 2022
  4. Study completion30 Sep 2023

Resources

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
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04162418
Sponsor's protocol ID
CP-005
Acronym
DEEPER LIMUS
Status last verified
Nov 2023
First submitted
11 Nov 2019
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan for sharing of IPD

Questions about this trial

What is this clinical trial studying?

A study testing Temporary Spur Stent System in people with Peripheral Arterial Disease and Critical Limb Ischemia, run by ReFlow Medical, Inc. at 1 site in Austria.

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 22 inclusion and 25 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 18 Nov 2023. 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 Austria. 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?

Rate of All-Cause Mortality, Major Amputation and Clinically Driven Target Lesion Revascularization (CD-TLR) 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?

On the ClinicalTrials.gov record for NCT04162418.

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 18 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in