NL-OMON56263CompletedNot Applicable
A Randomized Trial comparing the Drug-Eluting Stent (DES) Below-the-Knee (BTK) Vascular Stent System (DES BTK Vascular Stent System) vs Percutaneous Transluminal Angioplasty (PTA) Treating Infrapopliteal Lesions in Subjects With Critical Limb Ischemia - Saval Pivotal Trial
Boston Scientific Cooperation International0 sites20 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Pre-procedure Inclusion Criteria
- •1. Subject is 18 years or older and has signed and dated the trial informed
- •consent form (ICF). Note: For subjects in Japan who are less than 20 years of
- •age, the subject*s legal representative must provide written informed consent
- •in addition to the subject
- •2. Subject is willing and able to comply with the trial testing, procedures and
- •follow-up schedule
- •3. Subject has chronic, symptomatic lower limb ischemia, determined by
- •Rutherford categories 4 or 5 in the target limb, with wound(s) confined to
- •toes/forefoot
- •4. Subject is a male or non-pregnant female. If female of child-bearing
- •potential, and if sexually active must be using, or agree to use, a medically-
- •acceptable method of birth control as confirmed by the investigator
- •Intra-Procedure Inclusion Criteria
- •1. Stenotic, restenotic or occlusive target lesion(s) located in the
- •tibioperoneal trunk, anterior tibial, posterior tibial and/or peroneal
- •artery(ies).
- •Target lesion(s) must be at least 4cm above the ankle joint
- •A single target lesion per vessel, in up to 2 vessels, in a single limb
- •Degree of stenosis >= 70% by visual angiographic assessment
- •Reference vessel diameter (RVD) is between 2.5 - 3.25mm for phase A RCT
- •Total target lesion length (or series of lesion segments) to be treated is <=
- •140mm for phase A RCT after DMC approval for stent overlap (Note: Lesion
- •segment(s) must be fully covered with up to two DES BTK stents, if randomized
- •Total target lesion length (or series of lesion segments) to be treated is <=
- •140mm for phase B non-randomized (Note: Lesion segment(s) must be fully covered
- •with up to two DES BTK stents)
- •2. Target vessel(s) reconstitute(s) at or above the stenting limit zone (4cm
- •above the ankle joint)
- •3. Target lesion(s) is located in an area that may be stented without blocking
- •access to patent main branches
- •4. Treatment of all above the knee inflow lesion(s) is successful prior to
- •treatment of the target lesion
- •5. Guidewire has successfully crossed the target lesion(s)
Exclusion Criteria
- •Pre-Procedure Exclusion Criteria
- •1. Life expectancy <= 1year
- •2. Stroke <= 90 days prior to the procedure date
- •3. Prior or planned major amputation in the target limb
- •4. Previous surgery in the target vessel(s) (including prior ipsilateral crural
- •5. Previously implanted stent in the target vessel(s)
- •6. Failed PTA of target lesion/vessel <= 60 days prior to the procedure date
- •7. Renal failure as measured by a GFR <= 30ml/min per 1.73m2, measured <= 30 days
- •prior to the procedure date
- •8. Subject has a platelet count <= 50 or >= 600 X 103/µL <= 30 days prior to the
- •procedure date
- •9. NYHA class IV heart failure
- •10. Subject has symptomatic coronary artery disease (ie, unstable angina)
- •11. History of myocardial infarction or thrombolysis <= 90 days prior to the
- •procedure date
- •12. Non-atherosclerotic disease resulting in occlusion (eg, embolism, Buerger*s
- •disease, vasculitis)
- •13. Subject is currently taking Canagliflozin
- •14. Body Mass Index (BMI) <18
- •15. Active septicemia or bacteremia
- •16. Coagulation disorder, including hypercoagulability
- •17. Contraindication to anticoagulation or antiplatelet therapy
- •18. Known allergies to stent or stent components
- •19. Known allergy to contrast media that cannot be adequately pre-medicated
- •prior to the interventional procedure
- •20. Known hypersensitivity to heparin
- •21. Subject is on a high dose of steroids or is on immunosuppressive therapy
- •22. Subject is currently participating, or plans to participate in, another
- •investigational trial that may confound the results of this trial (unless
- •written approval is received from the Boston Scientific study team),
- •Intra-procedure Exclusion Criteria
- •1. Angiographic evidence of intra-arterial acute/subacute thrombus or
- •presence of atheroembolism
- •2. Treatment required in > 2 target vessels (Note: a target lesion
- •originating in one vessel and extending into another vessel is considered 1
- •target vessel)
- •3. Treatment requires the use of alternate therapy in the target
- •vessel(s)/lesion(s), (eg, atherectomy, cutting balloon, re-entry devices,
- •laser, radiation therapy)
- •4. Aneurysm is present in the target vessel(s)
- •5. Extremely calcified lesions
Investigators
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