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Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System (MIMICS-2)

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ClinicalTrials.gov Identifier: NCT02400905
Recruitment Status : Completed
First Posted : March 27, 2015
Results First Posted : January 18, 2019
Last Update Posted : March 25, 2020
Sponsor:
Collaborators:
ClinLogix. LLC
Yale Cardiovascular Research Group
Massachusetts General Hospital
Information provided by (Responsible Party):
Veryan Medical Ltd.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Peripheral Arterial Disease
Intervention Device: BioMimics 3D Stent System
Enrollment 271
Recruitment Details  
Pre-assignment Details  
Arm/Group Title BioMimics 3D Stent
Hide Arm/Group Description Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Period Title: Overall Study
Started 271
12-month Follow-up 256
Completed 0
Not Completed 271
Reason Not Completed
Ongoing Follow-up             256
Lost to Follow-up             6
Withdrawal by Subject             5
Death             3
Subject refused visit             1
Arm/Group Title BioMimics 3D Stent
Hide Arm/Group Description Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Overall Number of Baseline Participants 271
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 271 participants
68.4  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 271 participants
Female
91
  33.6%
Male
180
  66.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 271 participants
Hispanic or Latino
10
   3.7%
Not Hispanic or Latino
253
  93.4%
Unknown or Not Reported
8
   3.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 271 participants
American Indian or Alaska Native
0
   0.0%
Asian
31
  11.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
16
   5.9%
White
215
  79.3%
More than one race
0
   0.0%
Unknown or Not Reported
9
   3.3%
1.Primary Outcome
Title Primary Safety Endpoint (Freedom From a Composite of Major Adverse Events (MAE)
Hide Description 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.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with available 30 day follow-up
Arm/Group Title BioMimics 3D Stent
Hide Arm/Group Description:
Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Overall Number of Participants Analyzed 269
Measure Type: Count of Participants
Unit of Measure: Participants
268
  99.6%
2.Primary Outcome
Title Primary Effectiveness Endpoint (Primary Stent Patency Rate)
Hide Description Primary stent patency rate at 12 months.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title BioMimics 3D Stent
Hide Arm/Group Description:
Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Overall Number of Participants Analyzed 248
Measure Type: Count of Participants
Unit of Measure: Participants
181
  73.0%
3.Secondary Outcome
Title Secondary Safety (Overall MAE Rate at 30 Days)
Hide Description 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.
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with available 30 day follow-up
Arm/Group Title BioMimics 3D Stent
Hide Arm/Group Description:
Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Overall Number of Participants Analyzed 269
Measure Type: Count of Participants
Unit of Measure: Participants
Freedom from Death
269
 100.0%
Freedom from Major Amputation
269
 100.0%
Freedom from CD-TLR
268
  99.6%
4.Secondary Outcome
Title Long Term Safety (Overall MAE Rate at Month 12)
Hide Description Overall MAE rate at Month 12 and contribution of individual event rates to the overall MAE.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title BioMimics 3D Stent
Hide Arm/Group Description:
Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Overall Number of Participants Analyzed 258
Measure Type: Count of Participants
Unit of Measure: Participants
Freedom from MAE Number Analyzed 258 participants
223
  86.4%
Freedom from Death Number Analyzed 256 participants
253
  98.8%
Freedom from Major Amputation Number Analyzed 254 participants
254
 100.0%
Freedom from CD-TLR Number Analyzed 256 participants
224
  87.5%
5.Secondary Outcome
Title Long Term Safety (Overall Rate and Incidence of Type of Serious Adverse Events)
Hide Description Overall rate and incidence of type of serious adverse events from Day 0 through completion of Study follow-up at Month 36.
Time Frame 36 Months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Technical Success
Hide Description Percentage of subjects in which a final result of ≤50% residual diameter stenosis (in-stent) was achieved at index procedure
Time Frame Procedural (at end of index procedure)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with available baseline angiography
Arm/Group Title BioMimics 3D Stent
Hide Arm/Group Description:
Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
Overall Number of Participants Analyzed 269
Measure Type: Count of Participants
Unit of Measure: Participants
269
 100.0%
7.Secondary Outcome
Title Primary Stent Patency
Hide Description 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.
Time Frame Months 12 & 24
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Clinical Outcome (Rutherford Clinical Category)
Hide Description Comparison of Rutherford Clinical Category measured at Baseline, Day 30, Months 12 and 24.
Time Frame Baseline, Day 30, Months 12 & 24
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Clinical Outcome (Six-Minute Walk Test)
Hide Description Comparison of measured at Baseline, Day 30, Months 12 and 24 (subgroup of US investigational sites only).
Time Frame Baseline, Day 30, Months 12 & 24
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Functional Outcome (Ankle Brachial Index (ABI) Measurement)
Hide Description Comparison of the ankle brachial index (ABI) measurement at Baseline, within 30 days after index procedure, then at Months 12 and 24.
Time Frame Day 30, Months 12 & 24
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Functional Outcome (Walking Impairment Questionnaire)
Hide Description Comparison of the Walking Impairment Questionnaire at Baseline, within 30 days after index procedure, then at Months 12 and 24.
Time Frame Baseline, Day 30, Months 12 & 24
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Stent Integrity (Measured as Freedom From Stent Fracture)
Hide Description Stent integrity measured as freedom from stent fracture.
Time Frame Months 12, 24 & 36
Outcome Measure Data Not Reported
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BioMimics 3D Stent
Hide Arm/Group Description Implantation of BioMimics 3D nitinol stent using the BioMimics 3D Stent System
All-Cause Mortality
BioMimics 3D Stent
Affected / at Risk (%)
Total   3/271 (1.11%)    
Hide Serious Adverse Events
BioMimics 3D Stent
Affected / at Risk (%) # Events
Total   114/271 (42.07%)    
Blood and lymphatic system disorders   
Anemia   1/271 (0.37%)  1
Cardiac disorders   
Angina   6/271 (2.21%)  6
Congestive heart failure (CHF)   6/271 (2.21%)  6
Atrial fibrillation   5/271 (1.85%)  9
Myocardial infarction   3/271 (1.11%)  3
Myocardial ischemia   3/271 (1.11%)  3
Cardiac arrhythmia   1/271 (0.37%)  1
Ventricular tachycardia   1/271 (0.37%)  1
Gastrointestinal disorders   
Gastro-intestinal bleeding   2/271 (0.74%)  2
Infections and infestations   
Sepsis   3/271 (1.11%)  3
Infected peripheral wound   1/271 (0.37%)  2
Urinary tract infection (UTI)   1/271 (0.37%)  1
Injury, poisoning and procedural complications   
Arterial occlusion/thrombus at puncture site   2/271 (0.74%)  2
Vascular access complications   2/271 (0.74%)  2
Groin hematoma ≥ 5 cm, with or without surgical repair   1/271 (0.37%)  1
Nervous system disorders   
Seizure   1/271 (0.37%)  1
Stroke or other neurological complications   1/271 (0.37%)  1
Renal and urinary disorders   
Renal failure/renal insufficiency   2/271 (0.74%)  2
Respiratory, thoracic and mediastinal disorders   
Respiratory distress   2/271 (0.74%)  2
Pneumonia   1/271 (0.37%)  1
Vascular disorders   
Restenosis of treated segment   33/271 (12.18%)  37
Arterial stenosis (non-target)   25/271 (9.23%)  28
Restenosis   6/271 (2.21%)  7
Restenosis of treated vessel   4/271 (1.48%)  4
Thrombosis   4/271 (1.48%)  4
Limb ischemia   2/271 (0.74%)  4
Dissection   2/271 (0.74%)  2
Hypotension   2/271 (0.74%)  2
Pseudoaneurysm   2/271 (0.74%)  2
Abrupt occlusion   1/271 (0.37%)  1
Amputation (unplanned, spontaneous)   1/271 (0.37%)  1
Aneurysm   1/271 (0.37%)  2
Dissection (≥ Grade C) in target vessel requiring intervention   1/271 (0.37%)  1
Embolization, distal   1/271 (0.37%)  1
Hypertension   1/271 (0.37%)  1
Total occlusion of the peripheral artery   1/271 (0.37%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BioMimics 3D Stent
Affected / at Risk (%) # Events
Total   0/271 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nick Yeo
Organization: Veryan Medical
Phone: +44 1403 258984
EMail: nick.yeo@veryanmed.com
Layout table for additonal information
Responsible Party: Veryan Medical Ltd.
ClinicalTrials.gov Identifier: NCT02400905    
Other Study ID Numbers: CID-100
First Submitted: March 23, 2015
First Posted: March 27, 2015
Results First Submitted: November 5, 2018
Results First Posted: January 18, 2019
Last Update Posted: March 25, 2020