Back to resultsThe Biomimetic Stent and Vascular Functions Study
Primary Purpose
Peripheral Arterial Disease
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Bio-MIMICS 3D Stent
Innova Stent
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease
Eligibility Criteria
Inclusion Criteria:
- Peripheral artery disease
- Target lesions in the proximal (3 cm distal to the CFA-bifurcation) middle and distal SFA
- Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2,3,4
- Planed peripheral intervention TASC A-D
- Subject must be between 18 and 85 years old
- Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12 month angiographic evaluation
- Vessel diameter >/= 4.0 mm and </=7.0 mm
- Target lesion length < 140 mm (segment to be stented)
- Willing to comply with the specified follow-up evaluation
- Written informed consent prior to any study procedures
- Pretreatment with an adequately sized ballon (1:1 ration to nonstenotic vessel diameter)
- usage of Biomimics stent as described in the IFU, especially regarding stent diameters and vessel size
Exclusion Criteria:
- Bifurcational lesions of the CFA and lesions including the first 3 cm of the SFA, due to technical aspects of FMD measurement
- Requiring stent implantation in the PA
- Instent-Restenosis
- Thrombolysis within 72 Hours prior to the index procedure
- Aneurysm formations in the femoral artery or popliteal artery
- Concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy
- Unstable angina pectoris at the time of the enrollment
- Recent myocardial infarction or stroke <30 days prior to the index procedure
- Life expectancy less than 12 months
- Septicaemia at the time of enrollment
- Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb
- Known or suspected allergies or contraindications to aspirin, clopidogrel or heparin
- Presence of other hemodynamically significant outflow lesions in the target limb requiring a planned surgical intervention or endovascular procedure within 30 days after the index procedure
Sites / Locations
- University of Essen, Clinic of Cardiology and AngiologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bio-MIMICS Stent
Innova Stent
Arm Description
Helical shaped BioMimics 3D Stent
Conventional: Nitinol Stent
Outcomes
Primary Outcome Measures
Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure
FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery.
Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure
FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery.
Secondary Outcome Measures
Changes in pulse wave velocity
Changes in cardiovascular function measured by pulse wave velocity in m/s
Changes in augmentation index
Changes in cardiovascular function measured by augmentation index in %
Changes in vascular strain
Changes in cardiovascular function measured by vascular strain in %
Changes in peripheral perfusion determined by ABI (ankle brachial index)
ABI measurements are conducted using a Doppler probe on tibial and anterior artery locations. The highest value will be used for calculation and divided by the highest systolic brachial Doppler pressure
Primary patency (PP) of target lesion
Primary patency determined by PVR measurement with ultrasound
Changes in clinical symptoms
Clinical symptoms of patients determined by Walking impairment questionaire (WIQ)
Changes in six-minute walk test
Six-minute walk test determined by pain-free walking distance in m
Freedom from Target Lesion Revascularization
Freedom from Target Lesion Revascularization (FTLR)
Number of participants with treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by SDWS
Changes of inflammatory profile measured by hs-CRP in mg/dl
Blood samples are collected at the below mentioned time points
Changes of inflammatory profile measured by oxLDL in µg/l
Blood samples are collected at the below mentioned time points
Changes of inflammatory profile measured by Interleukin-6 in pg/ml
Blood samples are collected at the below mentioned time points
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05447052
Brief Title
The Biomimetic Stent and Vascular Functions Study
Official Title
The Biomimetic Stent and Vascular Functions Study-The MIMICS FLOW STUDY
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2021 (Actual)
Primary Completion Date
April 26, 2023 (Anticipated)
Study Completion Date
April 26, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Essen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
The aim of this IIT is to determine the potential improvement and impact of the BioMimics 3D Stent System in the SFA on local vascular function.
Detailed Description
The MIMICS FLOW Study is a single-center, single-blind, investigator-initiated, randomized parallel group trial.
The impact of a novel biomimetical stent with a helical curvature provides superior hemodynamic and biomechanical performance and advantages. Additionally, it promotes swirling blood flow, elevating wall sheer strength, which is patency-protective and might impact on vascular functions due to completely different vascular properties through altered blood flow.
The influence of the novel devices and stent-platforms with improved hemodynamic capabilities with respect to vasomotor of the vessel wall, vascular function and vascular compliance can be measured by FMD, arterial stiffness indices and vascular strain analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bio-MIMICS Stent
Arm Type
Experimental
Arm Description
Helical shaped BioMimics 3D Stent
Arm Title
Innova Stent
Arm Type
Active Comparator
Arm Description
Conventional: Nitinol Stent
Intervention Type
Device
Intervention Name(s)
Bio-MIMICS 3D Stent
Intervention Description
Bio-MIMICS Stent implantation
Intervention Type
Device
Intervention Name(s)
Innova Stent
Intervention Description
Innova Stent implantation
Primary Outcome Measure Information:
Title
Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure
Description
FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery.
Time Frame
1 month
Title
Change of flow-mediated vasodilation (FMD) of the nonstenotic segment of the proximal SFA after procedure
Description
FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Changes in pulse wave velocity
Description
Changes in cardiovascular function measured by pulse wave velocity in m/s
Time Frame
Baseline, followed at 1 and 12 months
Title
Changes in augmentation index
Description
Changes in cardiovascular function measured by augmentation index in %
Time Frame
Baseline, followed at 1 and 12 months
Title
Changes in vascular strain
Description
Changes in cardiovascular function measured by vascular strain in %
Time Frame
Baseline, followed at 1 and 12 months
Title
Changes in peripheral perfusion determined by ABI (ankle brachial index)
Description
ABI measurements are conducted using a Doppler probe on tibial and anterior artery locations. The highest value will be used for calculation and divided by the highest systolic brachial Doppler pressure
Time Frame
Baseline, followed at 1 and 12 months
Title
Primary patency (PP) of target lesion
Description
Primary patency determined by PVR measurement with ultrasound
Time Frame
Baseline, followed at 1 and 12 months
Title
Changes in clinical symptoms
Description
Clinical symptoms of patients determined by Walking impairment questionaire (WIQ)
Time Frame
Baseline, followed at 1 and 12 months
Title
Changes in six-minute walk test
Description
Six-minute walk test determined by pain-free walking distance in m
Time Frame
Baseline, followed at 1 and 12 months
Title
Freedom from Target Lesion Revascularization
Description
Freedom from Target Lesion Revascularization (FTLR)
Time Frame
Baseline, followed at 1 and 12 months
Title
Number of participants with treatment-related adverse events
Description
Number of participants with treatment-related adverse events as assessed by SDWS
Time Frame
Baseline, followed at 1 and 12 months
Title
Changes of inflammatory profile measured by hs-CRP in mg/dl
Description
Blood samples are collected at the below mentioned time points
Time Frame
Baseline, followed at 1 and 12 months
Title
Changes of inflammatory profile measured by oxLDL in µg/l
Description
Blood samples are collected at the below mentioned time points
Time Frame
Baseline, followed at 1 and 12 months
Title
Changes of inflammatory profile measured by Interleukin-6 in pg/ml
Description
Blood samples are collected at the below mentioned time points
Time Frame
Baseline, followed at 1 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Peripheral artery disease
Target lesions in the proximal (3 cm distal to the CFA-bifurcation) middle and distal SFA
Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2,3,4
Planed peripheral intervention TASC A-D
Subject must be between 18 and 85 years old
Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12 month angiographic evaluation
Vessel diameter >/= 4.0 mm and </=7.0 mm
Target lesion length < 140 mm (segment to be stented)
Willing to comply with the specified follow-up evaluation
Written informed consent prior to any study procedures
Pretreatment with an adequately sized ballon (1:1 ration to nonstenotic vessel diameter)
usage of Biomimics stent as described in the IFU, especially regarding stent diameters and vessel size
Exclusion Criteria:
Bifurcational lesions of the CFA and lesions including the first 3 cm of the SFA, due to technical aspects of FMD measurement
Requiring stent implantation in the PA
Instent-Restenosis
Thrombolysis within 72 Hours prior to the index procedure
Aneurysm formations in the femoral artery or popliteal artery
Concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy
Unstable angina pectoris at the time of the enrollment
Recent myocardial infarction or stroke <30 days prior to the index procedure
Life expectancy less than 12 months
Septicaemia at the time of enrollment
Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb
Known or suspected allergies or contraindications to aspirin, clopidogrel or heparin
Presence of other hemodynamically significant outflow lesions in the target limb requiring a planned surgical intervention or endovascular procedure within 30 days after the index procedure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christos Rammos, Professor
Phone
0201-723-84808
Email
christos.rammos@uk-essen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Tienush Rassaf, Professor
Phone
0201-723-4801
Email
tienush.rassaf@uk-essen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christos Rammos, Professor
Organizational Affiliation
University Hospital, Essen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Essen, Clinic of Cardiology and Angiology
City
Essen
State/Province
NRW
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christos Rammos, Prof.
Phone
+4920172384808
Email
christos.rammos@uk-essen.de
First Name & Middle Initial & Last Name & Degree
Tienush Rassaf, Univ.-Prof.
Phone
+492017234801
Email
tienush.rassaf@uk-essen.de
12. IPD Sharing Statement
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The Biomimetic Stent and Vascular Functions Study
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