Trial Outcomes & Findings for 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) (NCT NCT05358353)
NCT ID: NCT05358353
Last Updated: 2025-09-05
Results Overview
Technical Success is defined as \<30% residual stenosis in subjects treated with the Bare Temporary Spur Stent System
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
130 participants
Primary outcome timeframe
At the end of the Index Procedure
Results posted on
2025-09-05
Participant Flow
Participant milestones
| Measure |
Bare Temporary Spur Stent System
Treatment with the Temporary Bare Spur Stent System (Spur Stent System).
Bare Temporary Spur Stent System: Treatment of qualifying infrapopliteal arteries with the Bare Temporary Spur Stent System, in subjects with critical limb ischemia.
|
|---|---|
|
Overall Study
STARTED
|
130
|
|
Overall Study
COMPLETED
|
105
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
Bare Temporary Spur Stent System
n=130 Participants
Treatment with the Temporary Bare Spur Stent System (Spur Stent System).
Bare Temporary Spur Stent System: Treatment of qualifying infrapopliteal arteries with the Bare Temporary Spur Stent System, in subjects with critical limb ischemia.
|
|---|---|
|
Age, Continuous
|
69.7 years
STANDARD_DEVIATION 10.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
102 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
130 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At the end of the Index ProcedureTechnical Success is defined as \<30% residual stenosis in subjects treated with the Bare Temporary Spur Stent System
Outcome measures
| Measure |
Bare Temporary Spur Stent System
n=130 Participants
Treatment with the Temporary Bare Spur Stent System (Spur Stent System).
Bare Temporary Spur Stent System: Treatment of qualifying infrapopliteal arteries with the Bare Temporary Spur Stent System, in subjects with critical limb ischemia.
|
|---|---|
|
Primary Efficacy Endpoint: Percentage of Participants With Technical Success of the Bare Temporary Spur Stent
|
99.2 percentage of participants
|
PRIMARY outcome
Timeframe: 30 days post procedureNumber of participants with freedom from the occurrence of major adverse limb events (MALE) \[evaluated at 30 days post procedure\] and peri-operative death (POD) \[defined as all-cause mortality within 30 days post procedure\]. MALE is defined as: * Above-the-ankle amputation of the index limb * Major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving the infrapopliteal arteries.
Outcome measures
| Measure |
Bare Temporary Spur Stent System
n=130 Participants
Treatment with the Temporary Bare Spur Stent System (Spur Stent System).
Bare Temporary Spur Stent System: Treatment of qualifying infrapopliteal arteries with the Bare Temporary Spur Stent System, in subjects with critical limb ischemia.
|
|---|---|
|
Co-Primary Safety Endpoint: Percentage of Patients With no Major Adverse Limb Event (MALE) or Peri-operative Death (POD) at 30 Days Post Procedure
|
96.7 percentage of participants
|
Adverse Events
Bare Temporary Spur Stent System
Serious events: 30 serious events
Other events: 53 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Bare Temporary Spur Stent System
n=130 participants at risk
Treatment with the Temporary Bare Spur Stent System (Spur Stent System).
Bare Temporary Spur Stent System: Treatment of qualifying infrapopliteal arteries with the Bare Temporary Spur Stent System, in subjects with critical limb ischemia.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Cardiac disorders
Cardiac arrest
|
1.5%
2/130 • Number of events 2 • 1 month
|
|
Cardiac disorders
Acute MI
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Cardiac disorders
Atrial fibrillation
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Cardiac disorders
Cardiac failure acute
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Cardiac disorders
Cardiac failure congestive
|
0.77%
1/130 • Number of events 2 • 1 month
|
|
Cardiac disorders
Peripheral swelling
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Cardiac disorders
Ventricular tachycardic
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Endocrine disorders
Hyperglycemia
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Gastrointestinal disorders
Nausea
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Infections and infestations
Gangrene
|
1.5%
2/130 • Number of events 2 • 1 month
|
|
Infections and infestations
Osteomyelitis
|
1.5%
2/130 • Number of events 2 • 1 month
|
|
Infections and infestations
Sepsis
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Injury, poisoning and procedural complications
Fall
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Musculoskeletal and connective tissue disorders
lumbar spinal stenosis
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Nervous system disorders
Encephalopathy
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Skin and subcutaneous tissue disorders
Gangrene
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Surgical and medical procedures
Foot amputation
|
1.5%
2/130 • Number of events 2 • 1 month
|
|
Surgical and medical procedures
Toe amputation
|
2.3%
3/130 • Number of events 3 • 1 month
|
|
Surgical and medical procedures
Peripheral revascularization
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Vascular disorders
Peripheral artery occlusion
|
3.1%
4/130 • Number of events 4 • 1 month
|
|
Vascular disorders
Arterial occlusive disease
|
1.5%
2/130 • Number of events 2 • 1 month
|
|
Vascular disorders
Artery dissection
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Vascular disorders
Carotid artery stenosis
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Vascular disorders
Epistaxis
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Vascular disorders
Extremity necrosis
|
0.77%
1/130 • Number of events 2 • 1 month
|
|
Vascular disorders
Hypertensive crisis
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Vascular disorders
Peripheral ischemia
|
0.77%
1/130 • Number of events 1 • 1 month
|
Other adverse events
| Measure |
Bare Temporary Spur Stent System
n=130 participants at risk
Treatment with the Temporary Bare Spur Stent System (Spur Stent System).
Bare Temporary Spur Stent System: Treatment of qualifying infrapopliteal arteries with the Bare Temporary Spur Stent System, in subjects with critical limb ischemia.
|
|---|---|
|
Metabolism and nutrition disorders
Acute Kidney Injury
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Vascular disorders
Artery Dissection
|
2.3%
3/130 • Number of events 3 • 1 month
|
|
Surgical and medical procedures
Amputation
|
1.5%
2/130 • Number of events 2 • 1 month
|
|
Cardiac disorders
Angina pectoris
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Cardiac disorders
Atrial Fibrillation
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Cardiac disorders
Chest Pain
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Injury, poisoning and procedural complications
Fall
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Infections and infestations
Food Poisoning
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Surgical and medical procedures
Foot Amputation
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Infections and infestations
Gangrene
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Vascular disorders
Hematoma
|
1.5%
2/130 • Number of events 2 • 1 month
|
|
Nervous system disorders
Headache
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Vascular disorders
Hypertension
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Vascular disorders
Hypotension
|
1.5%
2/130 • Number of events 2 • 1 month
|
|
Injury, poisoning and procedural complications
Limb Injury
|
1.5%
2/130 • Number of events 2 • 1 month
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Nervous system disorders
Neuropathic Arthropathy
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Cardiac disorders
Oedema Peripheral
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
General disorders
Oedema Peripheral
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Metabolism and nutrition disorders
Oedema Peripheral
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Infections and infestations
Osteomyelitis
|
1.5%
2/130 • Number of events 2 • 1 month
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
2.3%
3/130 • Number of events 3 • 1 month
|
|
Cardiac disorders
Palpitations
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Vascular disorders
Peripheral Artery Dissection
|
1.5%
2/130 • Number of events 3 • 1 month
|
|
General disorders
Peripheral Swelling
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Vascular disorders
Peripheral Venous Disease
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
General disorders
Procedural Pain
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Investigations
Sars-CoV-2 test positive
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Infections and infestations
Serratia Infection
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Injury, poisoning and procedural complications
Skin Wound
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Skin and subcutaneous tissue disorders
Subcutaneous Abscess
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Cardiac disorders
Tachycardia
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Surgical and medical procedures
Toe Amputation
|
1.5%
2/130 • Number of events 2 • 1 month
|
|
Vascular disorders
Vasospasm
|
4.6%
6/130 • Number of events 6 • 1 month
|
|
Gastrointestinal disorders
Vomiting
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Skin and subcutaneous tissue disorders
Wound
|
0.77%
1/130 • Number of events 1 • 1 month
|
|
Injury, poisoning and procedural complications
Wound
|
0.77%
1/130 • Number of events 2 • 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place