A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL)
Phase: NA
Conditions: Peripheral Arterial Disease, Critical Limb Ischemia
Sponsor: ReFlow Medical, Inc.

 
 
 
PROTOCOL SYNOPSIS COVER PAGE 
 
A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR 
the tREatment of Vascular lesions located in the infrapoplitEal Arteries beLow the knee 
(DEEPER REVEAL) 
 
Protocol ID: CP-007 
 
NCT Identiﬁcation Number: NCT05358353 
 
Date of Document: 01 December 2022 

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1 PROTOCOL SUMMARY  
1.1 
Protocol Synopsis  
Title: 
A Prospective Single-Arm Multicenter StuDy to Evaluate the 
Performance of the BarE TEmporary SPur StEnt System foR 
the tREatment of Vascular lesions located in the infrapoplitEal 
Arteries beLow the knee (DEEPER REVEAL) 
Short Title: 
DEEPER REVEAL 
Protocol Number: 
CP-007 
Revision and Date: 
Rev B,  01 December 2022 
Test Device 
The Bare Temporary Spur Stent System manufactured by 
Reflow Medical 
Device Classification  
II 
Control Device 
None 
Trial Registration  
NCT05358353 
Study Design  
This is a prospective, multicenter, single arm study designed to 
evaluate the safety and efficacy of the Temporary Bare Spur 
Stent System (Spur Stent System).  
Intended Use 
The Bare Temporary Spur Stent System is intended for use in 
the infrapopliteal arteries ranging in diameter from 2.5mm to 
4.5mm for the treatment of critical limb ischemia (CLI). 
Planned Number of 
Subjects 
Up to 130 subjects will be enrolled at up to 50 investigational 
centers in the US and outside of the US. A minimum of 50% of 
subjects will be enrolled at US sites, and no single site will be 
permitted to enroll more than 20% of all subjects. 
Study Objectives  
Primary Objective: 
To compare the safety and efficacy of the Bare Temporary Spur 
Stent System in subjects with infrapopliteal critical limb 
ischemia (CLI) to a pre-defined performance goal (PG) based 
on standard percutaneous transluminal balloon angioplasty 
(PTA). 
 
Secondary Objective:  
To gather data on objective and subjective measures of clinical 
outcomes in this population.  
 
Primary Endpoints: 
Primary Efficacy Endpoint  
Technical success, defined as <30% residual stenosis within the 
treated lesion area by visual estimate on completion 
angiography. 
Co-Primary Safety Endpoint  
Freedom from the occurrence of major adverse limb events 
(MALE) [evaluated at 30 days post procedure] and peri-

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Representative (LAR), including a family member, sign 
on their behalf. 
2. Life expectancy greater than 1 year in the investigator’s 
opinion. 
3. Male or non-pregnant female ≥18 years of age at time of 
consent.  
4. Subjects must have chronic (greater than 14 days) 
symptoms of limb ischemia, determined by clinical 
symptoms of Rutherford class 4-5, 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. 
5. For subjects with bilateral disease, planned treatment of 
the contralateral limb must either be performed greater 
than or equal to 3 days prior to the index procedure or 
greater than or equal to 7 days following the index 
procedure. 
 
Angiographic Inclusion Criteria:  
1. Stenotic, restenotic, or occlusive lesions located in the 
infrapopliteal vessels, with target lesion that can be 
successfully crossed via the true lumen with a guidewire 
(no subintimal crossing).   
2. Iliac, SFA and popliteal inflow lesions can be treated 
using standard of care during the index procedure. 
Note:  
a) Inflow lesions treated intraprocedure must be 
treated first, prior to consideration of treatment 
of infrapopliteal lesions.  
b) Treatment of in-stent restenosis in inflow 
treatment is permitted, provided that stents are 
not fractured or otherwise compromised. 
c) Distal embolic protection is strongly encouraged 
in cases where atherectomy is used.  
d) Inflow lesions must have a healthy vessel 
segment of greater than 30 mm between the 
study lesion and the treated segment, defined as 
less than 50% stenosis without aneurysmal 
segments.  
e) Inflow treatment must be successful, prior to 
treatment of the target lesion, resulting in 
stenosis less than or equal to 30%, without 

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resulting flow limiting dissection, thrombus, or 
aneurysm by angiography. 
3. Target vessel(s) reconstitute(s) at or above the ankle, 
with the target treated segment ending at least 10 mm 
above the ankle joint.  
Note:  
a) If the anterior tibial or posterior tibial arteries  
are treated, there must be inline flow to the foot. 
b) If the peroneal artery is treated, there must be at 
least one collateral supplying the foot.  
c) In all cases, patent runoff (no lesions with 
greater than 50% stenosis) must be present via 
the dorsalis pedis and/or plantar arteries  
4. Target lesion must be located in the tibial arteries. If 
vessel sizing remains appropriate, treatment may extend 
into the distal popliteal (P3) segment. 
5. Target vessel reference diameter is measured to be 
between 2.5 to 4.5 mm in diameter assessed by one of 
the following methods after successful completion of 
guidewire crossing of the lesion site: 
a.  Intravascular Ultrasound (IVUS) (primary) 
b.  Visual estimate using Angiography (secondary) 
6. Target lesion length is less than or equal to 210mm in 
length. Tandem lesions that are less than or equal to 4 
cm should be treated as one lesion. Multiple discrete 
lesions may be treated provided cumulative length is 
less than or equal to 210 mm.  
7. Successful predilatation of the target lesion without 
resulting flow limiting dissection, thrombus, or 
aneurysm by angiography prior to the insertion of the 
Bare Temporary Spur Stent System. 
8. Only one limb and one contiguous vessel may be 
enrolled per subject. If required, a second modality may 
be used for treatment in the non-target infrapopliteal 
vessel.  
Note:  
a) Distal embolic protection is strongly 
recommended in cases using atherectomy. 
b) Treatment of the target vessel/lesion may be 
performed only if treatment of the non-target 
lesion is successful without resulting flow 
limiting (Type D or greater) dissection, 
thrombus, or aneurysm by angiography. 

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c) Treatment of non-target lesions must be parallel 
to, and not contiguous with, the target lesion. 
9. If pre-screening with duplex ultrasound, angiography, 
CTA, or MRA has been performed less than or equal to 
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.  
10. Retrograde access (in the infrapopliteal arteries) is 
permitted for lesion crossing; however, the Bare 
Temporary Spur Stent System must be deployed from 
antegrade (above the knee, either ipsilateral or 
contralateral) access. 
 
Exclusion Criteria: 
Pre-procedure Exclusion Criteria:  
1.   Subject unwilling or unlikely to comply with the 1-year 
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 systemic infection that is not 
controlled at the time of the procedure, including 
septicemia or bacteremia. 
4.   Subject has osteomyelitis proximal to the phalanges. 
Osteomyelitis in the digit(s) of the target foot is 
permitted. 
5.   Wounds must be confined to the foot below the ankle. 
Heel wounds are excluded.   
6.   Planned major (above the ankle) amputation of the 
target limb. A planned or previous minor (trans 
metatarsal amputation or digit amputation) is permitted. 
7.   Myocardial infarction (MI) or stroke within 90 days 
prior to the index procedure. 
8.   Symptomatic acute heart failure NYHA class III or 
greater.  
9. Impaired renal function (eGFR less than or equal to 25 
mL/min) within 30 days of procedure or end stage renal 
disease on dialysis. 
10. Inability to tolerate dual antiplatelet and/or 
anticoagulation therapy, including a history of severe 
bleeding or coagulopathy. 
11. Known allergies or sensitivities to heparin, antiplatelet 
drugs, other anticoagulant therapies which could not be 

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substituted, or an allergy to contrast media that cannot 
be adequately pre-treated prior to the index procedure. 
12. The subject is currently enrolled in another 
investigational device or drug trial that interferes with 
the study endpoints.  
13. Known allergy to nitinol or nickel.  
14. Bypass surgery of the target vessel(s). Prior bypass 
above the level of the infrapopliteal arteries is 
permitted. 
 
Angiographic Exclusion Criteria 
1. 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. 
2. Fractured or otherwise compromised stents or dissection 
repair devices in the target vessel or inflow vessel.  
3. In-stent restenosis in the target vessel, including 
restenosis of dissection repair devices. 
4. Previous treatment of the target vessel less than or equal 
to 90 days prior to index procedure. 
5.  Angiographic evidence of thrombus within target limb. 
6.  Extremely severe calcification that, in the investigator’s 
opinion, would not be amenable to PTA.   
7.  Type D dissections or greater incurred during CTO 
crossing (see Appendix I for definitions). 
8. Significant (greater than or equal to 50%) stenosis of 
inflow arteries or unsuccessful treatment of inflow 
lesions. 
9. Distance from access to lesion is too long for a 135 cm 
working length of the Bare Temporary Spur Stent 
System catheter.   
Analysis Plan 
Primary Efficacy Endpoint 
The primary efficacy endpoint hypothesis is that technical 
success (defined as <30% residual stenosis in subjects treated 
with the Bare Temporary Spur Stent System) meets a 
performance goal 
based on historical technical 
success rates with percutaneous transluminal balloon 
angioplasty (PTA) for below-the-knee infrapopliteal artery 
disease. 
A sample size of 130 evaluable subjects provides
power 
to demonstrate that the PG has been met at a 1-sided alpha of 
0.05 using the Exact Binomial Test, assuming that the observed 

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• 
Initiation of dual antiplatelet therapy (DAPT), if not 
already started  
• 
Adverse event assessment  
• 
Device deficiency assessment 
 
Visit 3a [2 weeks] (for Rutherford 5 subjects only), will consist 
of:  
• 
Wound evaluation, including pictures  
• 
Adverse event assessment 
 
Visits 3b-6 (1, 3, 6, 12 months), will consist of:  
• 
Ankle Brachial Index (ABI) and Toe Brachial Index 
(TBI) 
• 
Medications, including DAPT  
• 
Wound evaluation, including pictures, if applicable  
• 
Rutherford score  
• 
Adverse event assessment  
• 
VascuQOL-25 at 1, 6, 12 months 
• 
EQ-5D at 1, 6, 12, months 
• 
Blood draw within 1 month post-procedure, including 
creatinine, eGFR, hemoglobin level, white blood cell 
count, and platelet level. 
• Duplex ultrasound of index limb at 1, 3, 6, and 12 
months  
 
*NOTE: Subjects in whom Bare Temporary Spur Stent System 
was introduced, but was not ultimately used to treat a lesion, 
will be followed to 30 days for safety. 
 
Sponsor: 
Reflow Medical, Inc. 
208 Avenida Fabricante, #100 
San Clemente, CA 92672