BioMimics 3D Stent Clinical Investigation: The Mimics Study

NCT02163863 | Completed DMC

• 1 other identifier: Mimics
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Primary purpose of the Mimics Study is to evaluate the safety and performance of the BioMimics 3D Stent System in the treatment of symptomatic SFA/proximal popliteal disease.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral arterial disease (PAD); Peripheral vascular disease (PVD); Biomimetic stent; Helical centerline

Outcome Measures

Primary Outcomes (2)

• Primary safety endpoint

  Freedom from major adverse events defined as death, amputation and target lesion revascularization (TLR)

  30 days

• Primary performance endpoint

  Freedom from clinically driven TLR

  6 months

Secondary Outcomes (5)

• Acute procedural outcomes

  Within 30 days of the procedure

• Post implant anatomical outcomes

  Immediately post implant but within the index procedure

• Mechanical outcomes

  30 days, 6, 12 and 24 months

• Haemodynamic outcomes

  discharge, 30 days, 6, 12 and 24 months

• Clinical and functional outcomes

  discharge, 30 days, 6, 12 and 24 months

Study Arms (2)

BioMimics 3D

EXPERIMENTAL

The BioMimics 3D Stent System, delivering a self-expanding Nitinol stent with 3D helical centerline geometry.

Device: Femoropopliteal stenting

Control

ACTIVE COMPARATOR

CR Bard LifeStent System, delivering a self-expanding Nitinol stent

Device: Femoropopliteal stenting

Interventions

Femoropopliteal stenting DEVICE

BioMimics 3D; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years of age
• The subject or legal guardian has been informed of the nature of the study and agrees to its provisions and has provided informed written consent
• The subject is willing to be available for the appropriate follow-up for the duration of the study
• Rutherford 1-4(mild claudication to ischemic rest pain), with an occlusion or de novo and/or restenotic SFA/PPA lesion ≥50% and ABI/TBI \<0.90/0.80
• Single target lesion located at least 1 cm distal to the take-off of the profunda femoris artery and at least 3 cm proximal to the highest point of the cortical margin of the femur
• Target vessel reference diameter is ≥3.5 mm and ≤7.0 mm
• Target lesion length is ≥4.0 cm and ≤10.0 cm, and must be intended to be covered with one single stent only. A second stent is permitted to be placed only if, in the physician's opinion, the first stent did not achieve an optimum clinical result
• Adequate distal run-off to the ankle in the target limb (defined as having at least one patent calf vessel \<50% stenosed
• Life expectancy \>24 months

You may not qualify if:

• Women who do not have a negative serum or urine pregnancy test documented within 7 days prior to enrollment (if not already post menopausal) or women who do not agree to use an adequate birth control method for up to 24 months after Device implantation
• An uncontrolled infectious disease
• A condition that inhibits radiographic visualisation of the arteries
• Any condition that precludes safe access with PTA devices, such as: excessive common femoral artery disease, unresolved fresh thrombus in the target lesion/vessel, or a target lesion/vessel that is excessively tortuous or calcified
• Known allergy to, or intolerance of, Nitinol
• Known intolerance of aspirin and/or clopidogrel
• Known hypersensitivity to contrast media which cannot be pre-treated
• Participation in another device or drug study. Subject must have completed the follow- up phase of any previous study at least 30 days prior to enrollment into this study. The subject may only be enrolled in this study once
• The subject is unable and/or unwilling to cooperate with study procedures or required follow-up visits
• History of bleeding diatheses or coagulopathy or will refuse blood transfusions
• Known impaired renal function, defined as creatinine \>2.5 mg/dl except subjects under chronic renal replacement therapy
• Known platelet count \<80,000 cells/mm3 or \>700,000 cells/mm3
• Known WBC of \<3,000 cells/mm3
• The subject is unable to bend lower limbs (full knee flexion) and/or has a knee prosthesis
• Previous treatment of the target lesion 6 months prior to enrollment; previous femoropopliteal bypass in the target vessel; previous stenting of the target lesion

Sponsors & Collaborators

• Veryan Medical Ltd.: lead

Study Sites (1)

Universitaets-Herzzentrum Freiburg-Bad Krozingen

Bad Krozingen, Germany

Location

Related Publications (1)

• Zeller T, Gaines PA, Ansel GM, Caro CG. Helical Centerline Stent Improves Patency: Two-Year Results From the Randomized Mimics Trial. Circ Cardiovasc Interv. 2016 Jun;9(6):e002930. doi: 10.1161/CIRCINTERVENTIONS.115.002930.

  PMID: 27208046 RESULT

Related Links

• Helical Centerline Stent Improves Patency: Two-Year Results From the Randomized Mimics Trial

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Thomas Zeller, M.D.

  Universitäts-Herzzentrum Freiburg Bad Krozingen

  PRINCIPAL INVESTIGATOR

• Sebastian Sixt, MD

  Medizinisches Versorgungszentrum Hamburg

  PRINCIPAL INVESTIGATOR

• Henrik Schroeder, MD

  Zentrum für Minimal Invasive Therapie Berlin

  PRINCIPAL INVESTIGATOR

• Horst Sievert, MD

  Cardiovascular Center Frankfurt

  PRINCIPAL INVESTIGATOR

• Karl-Ludwig Schulte, MD

  Königin Elisabeth Herzberge Berlin

  PRINCIPAL INVESTIGATOR

• Gunnar Tepe, MD

  Klinikum Rosenheim

  PRINCIPAL INVESTIGATOR

• Giovanni Torsello, MD

  St. Franziskus Hospital Münster

  PRINCIPAL INVESTIGATOR

• Dierk Scheinert, MD

  Park-Krankenhaus Leipzig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2014
• First Posted: June 16, 2014
• Study Start: February 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: July 1, 2014
• Last Updated: November 14, 2019

Record last verified: 2019-11

Locations

DE (1)