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

  • STATUS
    Recruiting
  • End date
    Dec 14, 2022
  • participants needed
    10
  • sponsor
    ReFlow Medical, Inc.
Updated on 22 February 2021
arteriopathy
angiography
stenosis
aneurysm
medical therapy
endovascular intervention
ischemia
intravascular ultrasound
stenotic
limb ischemia
rest pain
intermittent claudication
atherectomy
duplex ultrasound

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.

Details
Condition Peripheral vascular disease, Circulation Disorders, Peripheral vascular disease, peripheral arterial disease, Peripheral Arterial Disease (PAD), Circulation Disorders, Critical Limb Ischemia, Critical Limb Ischaemia, Peripheral Arterial Disease (PAD), peripheral arterial diseases, peripheral artery disease
Treatment Temporary Spur Stent System
Clinical Study IdentifierNCT04162418
SponsorReFlow Medical, Inc.
Last Modified on22 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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)
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

Exclusion Criteria

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
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
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