Trial Outcomes & Findings for Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System (NCT NCT02400905)

NCT ID: NCT02400905

Last Updated: 2021-06-04

Results Overview

Freedom from a composite of major adverse events (MAE) comprising death, any major amputation performed on the target limb or clinically-driven target lesion revascularization (TLR) through 30 days.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 271 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2021-06-04

Participant Flow

Participant milestones

Measure	BioMimics 3D Stent Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Overall Study STARTED	271
Overall Study 30-Days Follow-up	268
Overall Study 12-Months Follow-up	256
Overall Study 24-Months Follow-up	225
Overall Study 36 Months-Follow-up	208
Overall Study COMPLETED	208
Overall Study NOT COMPLETED	63

Reasons for withdrawal

Measure	BioMimics 3D Stent Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Overall Study Death	24
Overall Study Lost to Follow-up	18
Overall Study Withdrawal by Subject	16
Overall Study Physician Decision	4
Overall Study Other	1

Baseline Characteristics

Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System

Baseline characteristics by cohort

Measure	BioMimics 3D Stent n=271 Participants Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Age, Continuous	68.4 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	91 Participants n=5 Participants
Sex: Female, Male Male	180 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	253 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	31 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants
Race (NIH/OMB) White	215 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Subjects with available 30 day follow-up

Freedom from a composite of major adverse events (MAE) comprising death, any major amputation performed on the target limb or clinically-driven target lesion revascularization (TLR) through 30 days.

Outcome measures

Measure	BioMimics 3D Stent n=269 Participants Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Primary Safety Endpoint (Freedom From a Composite of Major Adverse Events (MAE)	268 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Subjects were included in analysis population if they had imaging data qualifying as a 12m visit and/or subjects without imaging data who experienced a CDTLR through 12 months. Additionally, if a subject is missing stent patency status at the 12m window but found to be patent at a later out-of-window date, subject was considered patent at 12 months

The primary effectiveness endpoint of the MIMICS-2 Study was defined as the primary stent patency rate at 12 months. Patency was defined as no significant reduction in luminal diameter (< 50% diameter stenosis) since the index procedure. Loss of patency was determined by an independent core laboratory when the peak systolic velocity ratio (PSVR) exceeds 2.0, or where angiography revealed > 50% diameter stenosis, or where the subject had a CDTLR.

Outcome measures

Measure	BioMimics 3D Stent n=249 Participants Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Primary Effectiveness Endpoint (Primary Stent Patency Rate)	182 Participants

SECONDARY outcome

Timeframe: 30 Days

Population: Subjects with available 30 day follow-up

Contribution of individual MAE rates for death, major amputation performed on the target limb and clinically-driven target lesion revascularization to the overall MAE rate at 30 days.

Outcome measures

Measure	BioMimics 3D Stent n=269 Participants Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Secondary Safety (Overall MAE Rate at 30 Days) Freedom from Death	269 Participants
Secondary Safety (Overall MAE Rate at 30 Days) Freedom from Major Amputation	269 Participants
Secondary Safety (Overall MAE Rate at 30 Days) Freedom from CD-TLR	268 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Subjects are included in the analysis population if (i) they have sufficient follow-up (at least 12 months less 30 days), or (ii) they have had the event of interest (each event is considered separately).

Overall MAE rate at Month 12 and contribution of individual event rates to the overall MAE.

Outcome measures

Measure	BioMimics 3D Stent n=261 Participants Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Long Term Safety (Overall MAE Rate at Month 12) Freedom from MAE	226 Participants
Long Term Safety (Overall MAE Rate at Month 12) Freedom from Death	257 Participants
Long Term Safety (Overall MAE Rate at Month 12) Freedom from Major Amputation	258 Participants
Long Term Safety (Overall MAE Rate at Month 12) Freedom from CD-TLR	227 Participants

SECONDARY outcome

Timeframe: 36 Months

Overall rate and incidence of type of serious adverse events from Day 0 through completion of Study follow-up at Month 36.

Outcome measures

Measure	BioMimics 3D Stent n=271 Participants Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Number of Participants With Serious Adverse Events total number of participants	271 Participants
Number of Participants With Serious Adverse Events All SAE (In-hospital)	13 Participants
Number of Participants With Serious Adverse Events All SAE (30 Days)	26 Participants
Number of Participants With Serious Adverse Events All SAE (12 Months)	114 Participants
Number of Participants With Serious Adverse Events All SAE (24 Months)	146 Participants
Number of Participants With Serious Adverse Events All SAE (36 Months)	164 Participants

SECONDARY outcome

Timeframe: Procedural (at end of index procedure)

Population: Subjects with available baseline angiography

Percentage of subjects in which a final result of ≤50% residual diameter stenosis (in-stent) was achieved at index procedure

Outcome measures

Measure	BioMimics 3D Stent n=269 Participants Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Technical Success	269 Participants

SECONDARY outcome

Timeframe: Months 12 & 24

Population: Relevant data was not collected to provide the outcome analysis

Determined at Months-12 and 24 using values of: PSVR >2.0, >2.4; >2.5; and >3.5, each to indicate loss of patency on duplex ultrasound or where angiography reveals >50% diameter stenosis or where the subject undergoes clinically-driven TLR.

Further analysis of the patency data purely using a reference PSVR of >2.4, >2.5 and >3.5 was not feasible from the data that was collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Day 30, Months 12 & 24

Population: Number of participants participating in the study changed at 30 Days, 12 Months and 24 Months

Comparison of Rutherford Clinical Category measured at Baseline, Day 30, Months 12 and 24.

Categories 0 - Asymptomatic

1. - Mild claudication

2. - Moderate claudication

3. - Severe claudication

4. - Ischemic rest pain

5. - Minor tissue loss

6. - Major tissue loss

Outcome measures

Measure	BioMimics 3D Stent n=268 Participants Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Number of Participants With Improvement of Rutherford Clinical Category by 1 or More Improvement of Rutherford Category of 1 or more at 30 Days	233 Participants
Number of Participants With Improvement of Rutherford Clinical Category by 1 or More Improvement of Rutherford Category of 1 or more at 12 Months	216 Participants
Number of Participants With Improvement of Rutherford Clinical Category by 1 or More Improvement of Rutherford Category of 1 or more at 24 Months	195 Participants

SECONDARY outcome

Timeframe: Baseline, Day 30, Months 12 & 24

Population: Number of participants analysed changed over the time period

Comparison of measured at Baseline, Day 30, Months 12 and 24 (subgroup of US investigational sites only).

Outcome measures

Measure	BioMimics 3D Stent n=22 Participants Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Clinical Outcome (Six-Minute Walk Test) Baseline	230 yards Standard Deviation 162
Clinical Outcome (Six-Minute Walk Test) 30 Days	349 yards Standard Deviation 221
Clinical Outcome (Six-Minute Walk Test) 12 Months	278 yards Standard Deviation 143
Clinical Outcome (Six-Minute Walk Test) 24 Months	405 yards Standard Deviation 140

SECONDARY outcome

Timeframe: Baseline, Day 30, Months 12 & 24

Population: Number of participants assessed for ABI index measurement at Baseline, within 30 days after index procedure, then at Months 12 and 24.

Comparison of the ankle brachial index (ABI) measurement at Baseline, within 30 days after index procedure, then at Months 12 and 24.

Outcome measures

Measure	BioMimics 3D Stent n=271 Participants Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Functional Outcome (Ankle Brachial Index (ABI) Measurement) ABI at Baseline	0.70 ABI Standard Deviation 0.20
Functional Outcome (Ankle Brachial Index (ABI) Measurement) ABI at 30 Days	0.98 ABI Standard Deviation 0.16
Functional Outcome (Ankle Brachial Index (ABI) Measurement) ABI at 12 Months	0.92 ABI Standard Deviation 0.19
Functional Outcome (Ankle Brachial Index (ABI) Measurement) ABI at 24 Months	0.94 ABI Standard Deviation 0.20

SECONDARY outcome

Timeframe: Baseline, Day 30, Months 12 & 24

Population: Walking Impairment Questionnaire score at Baseline, within 30 days after index procedure, then at Months 12 and 24.

Comparison of the Walking Impairment Questionnaire at Baseline, within 30 days after index procedure, then at Months 12 and 24.

The WIQ consists of 3 primary categories assessing walking distance, stair-climbing, and walking speed, as previously described. Individuals are asked to rate the degree of difficulty of various activities with responses ranging from 0 (unable) to 4 (none).

Outcome measures

Measure	BioMimics 3D Stent n=270 Participants Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Change of Walking Impairment Questionnaire Score Baseline WIQ score	0.28 scores on a scale Standard Deviation 0.24
Change of Walking Impairment Questionnaire Score 30 Days WIQ score	0.58 scores on a scale Standard Deviation 0.32
Change of Walking Impairment Questionnaire Score 12 Months WIQ score	0.58 scores on a scale Standard Deviation 0.31
Change of Walking Impairment Questionnaire Score 24 Months WIQ score	0.56 scores on a scale Standard Deviation 0.31

SECONDARY outcome

Timeframe: Months 12, 24 & 36

Population: Number of participants with no fracture in study stent at 12, 24 and 36 Months assessment.

Stent integrity measured as freedom from fracture, defined as clear interruption of a stent strut observed in a minimum of two projections, determined by core lab examination of X-rays taken with the leg in extension at 12, 24 and 36 Months.

Outcome measures

Measure	BioMimics 3D Stent n=229 Participants Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Number of Participants With Freedom From Stent Fracture Freedom from stent fracture at 12 Months	229 Participants
Number of Participants With Freedom From Stent Fracture Freedom from stent fracture at 24 Months	204 Participants
Number of Participants With Freedom From Stent Fracture Freedom from stent fracture at 36 Months	102 Participants

Adverse Events

BioMimics 3D Stent

Serious events: 164 serious events

Other events: 177 other events

Deaths: 24 deaths

Serious adverse events

Measure	BioMimics 3D Stent n=271 participants at risk Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Vascular disorders Restenosis of treated segment	17.3% 47/271 • Number of events 60 • 36 months Site reported serious adverse events.
Vascular disorders Arterial stenosis (non-target)	14.0% 38/271 • Number of events 51 • 36 months Site reported serious adverse events.
Vascular disorders Restenosis	5.2% 14/271 • Number of events 21 • 36 months Site reported serious adverse events.
Vascular disorders Restenosis of treated vessel	4.4% 12/271 • Number of events 15 • 36 months Site reported serious adverse events.
Vascular disorders Thrombosis	1.5% 4/271 • Number of events 4 • 36 months Site reported serious adverse events.
Vascular disorders Limb ischemia	1.5% 4/271 • Number of events 6 • 36 months Site reported serious adverse events.
Vascular disorders Dissection	0.74% 2/271 • Number of events 2 • 36 months Site reported serious adverse events.
Vascular disorders Hypotension	0.74% 2/271 • Number of events 2 • 36 months Site reported serious adverse events.
Vascular disorders Pseudoaneurysm	0.74% 2/271 • Number of events 2 • 36 months Site reported serious adverse events.
Vascular disorders Abrupt occlusion	0.37% 1/271 • Number of events 1 • 36 months Site reported serious adverse events.
Vascular disorders Amputation (unplanned, spontaneous)	0.37% 1/271 • Number of events 1 • 36 months Site reported serious adverse events.
Vascular disorders Aneurysm	0.74% 2/271 • Number of events 3 • 36 months Site reported serious adverse events.
Vascular disorders Dissection (≥ Grade C) in target vessel requiring intervention	0.37% 1/271 • Number of events 1 • 36 months Site reported serious adverse events.
Vascular disorders Embolization, distal	0.37% 1/271 • Number of events 1 • 36 months Site reported serious adverse events.
Vascular disorders Hypertension	0.37% 1/271 • Number of events 1 • 36 months Site reported serious adverse events.
Vascular disorders Total occlusion of the peripheral artery	1.5% 4/271 • Number of events 6 • 36 months Site reported serious adverse events.
Cardiac disorders Angina	3.7% 10/271 • Number of events 13 • 36 months Site reported serious adverse events.
Cardiac disorders Congestive heart failure (CHF)	3.7% 10/271 • Number of events 14 • 36 months Site reported serious adverse events.
Cardiac disorders Atrial fibrillation	3.7% 10/271 • Number of events 14 • 36 months Site reported serious adverse events.
Cardiac disorders Myocardial infarction	4.8% 13/271 • Number of events 18 • 36 months Site reported serious adverse events.
Cardiac disorders Myocardial ischemia	1.8% 5/271 • Number of events 6 • 36 months Site reported serious adverse events.
Cardiac disorders Cardiac arrhythmia	1.5% 4/271 • Number of events 4 • 36 months Site reported serious adverse events.
Cardiac disorders Ventricular tachycardia	0.37% 1/271 • Number of events 1 • 36 months Site reported serious adverse events.
Blood and lymphatic system disorders Anemia	0.74% 2/271 • Number of events 2 • 36 months Site reported serious adverse events.
Gastrointestinal disorders Gastro-intestinal bleeding	1.1% 3/271 • Number of events 4 • 36 months Site reported serious adverse events.
Infections and infestations Sepsis	2.2% 6/271 • Number of events 7 • 36 months Site reported serious adverse events.
Infections and infestations Infected peripheral wound	0.37% 1/271 • Number of events 2 • 36 months Site reported serious adverse events.
Infections and infestations Urinary tract infection (UTI)	1.1% 3/271 • Number of events 3 • 36 months Site reported serious adverse events.
Injury, poisoning and procedural complications Arterial occlusion/thrombus at puncture site	0.74% 2/271 • Number of events 2 • 36 months Site reported serious adverse events.
Injury, poisoning and procedural complications Vascular access complications	0.74% 2/271 • Number of events 2 • 36 months Site reported serious adverse events.
Injury, poisoning and procedural complications Groin hematoma ≥ 5 cm, with or without surgical repair	0.37% 1/271 • Number of events 1 • 36 months Site reported serious adverse events.
Nervous system disorders Seizure	0.37% 1/271 • Number of events 1 • 36 months Site reported serious adverse events.
Nervous system disorders Stroke or other neurological complications	1.8% 5/271 • Number of events 5 • 36 months Site reported serious adverse events.
Renal and urinary disorders Renal failure/renal insufficiency	2.6% 7/271 • Number of events 7 • 36 months Site reported serious adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory distress	1.1% 3/271 • Number of events 3 • 36 months Site reported serious adverse events.
Respiratory, thoracic and mediastinal disorders Pneumonia	2.2% 6/271 • Number of events 7 • 36 months Site reported serious adverse events.
Immune system disorders Allergic reaction (medication, contrast media, device, etc.)	0.37% 1/271 • Number of events 1 • 36 months Site reported serious adverse events.
Vascular disorders Amputation (planned)	0.37% 1/271 • Number of events 1 • 36 months Site reported serious adverse events.
Blood and lymphatic system disorders Bleeding from anticoagulant or antiplatelet medications s	0.37% 1/271 • Number of events 1 • 36 months Site reported serious adverse events.
Blood and lymphatic system disorders Haemorrhage, with or without transfusion	0.37% 1/271 • Number of events 1 • 36 months Site reported serious adverse events.
Cardiac disorders Death (MAE if cardiovascular-related)	1.8% 5/271 • Number of events 5 • 36 months Site reported serious adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.37% 1/271 • Number of events 1 • 36 months Site reported serious adverse events.
Nervous system disorders Transient ischemic attack (TIA)	0.37% 1/271 • Number of events 1 • 36 months Site reported serious adverse events.
Investigations Other	35.1% 95/271 • Number of events 172 • 36 months Site reported serious adverse events.

Other adverse events

Measure	BioMimics 3D Stent n=271 participants at risk Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Cardiac disorders Angina	6.6% 18/271 • Number of events 22 • 36 months Site reported serious adverse events.
Vascular disorders Arterial stenosis (non-target)	18.5% 50/271 • Number of events 68 • 36 months Site reported serious adverse events.
Vascular disorders Restenosis	6.6% 18/271 • Number of events 27 • 36 months Site reported serious adverse events.
Vascular disorders Restenosis of treated segment	23.2% 63/271 • Number of events 77 • 36 months Site reported serious adverse events.
Vascular disorders Restenosis of treated vessel	5.2% 14/271 • Number of events 18 • 36 months Site reported serious adverse events.
Injury, poisoning and procedural complications Vascular access complications	5.2% 14/271 • Number of events 16 • 36 months Site reported serious adverse events.

Additional Information

Nick Yeo

Veryan Medical

Phone: +44 1403 258984

Email: nick.yeo@veryanmed.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60