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Trial record 1 of 3 for:    SAVAL
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The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia (SAVAL)

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ClinicalTrials.gov Identifier: NCT03551496
Recruitment Status : Active, not recruiting
First Posted : June 11, 2018
Last Update Posted : March 21, 2023
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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Brief Summary:
Two phased global, prospective, multicenter clinical trial designed to demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs. percutaneous transluminal angioplasty (PTA).

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Combination Product: Drug Eluting Stent - Below the Knee Device: Standard PTA Control Arm Phase 3

Detailed Description:

Phase A: A global, prospective, multicenter, 2:1 randomized trial evaluating the safety and effectiveness of the DES BTK Vascular Stent System compared to standard percutaneous transluminal angioplasty to treat infrapopliteal artery lesions in subjects with critical limb ischemia(CLI). Phase A RCT will begin with one size of the device: 3.5 mm x 80 mm.

Phase B: A global, prospective, multicenter, non-randomized trial collecting additional safety and effectiveness data for the DES BTK Vascular Stent System to treat infrapopliteal artery lesions in subjects with CLI. Additional stent sizes will be added to the trial upon regulatory approval.

Approximately 201 subjects will be randomized/enrolled to support a 2:1 randomization in the phase A RCT. Approximately 100 additional subjects are expected to be enrolled in phase B non-randomized which is structured as a single arm where the enrolled subjects are treated with the DES BTK Vascular Stent System.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Approximately 201 subjects will be randomized in a 2:1 fashion for phase A RCT. Randomizations will be stratified by investigational center and lesion length with 2 subjects receiving the DES BTK for every 1 subject receiving treatment with standard PTA. Approximately 100 additional subjects will be enrolled in non-randomized phase B where the enrolled subjects are treated with the DES BTK.
Masking: Single (Outcomes Assessor)
Masking Description: A review of the wound assessment data will be completed by independent reviewer(s) who will be blinded to the randomized therapy.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 31, 2018
Actual Primary Completion Date : April 21, 2022
Estimated Study Completion Date : March 31, 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: DES BTK
Treatment with DES BTK
 Combination Product: Drug Eluting Stent - Below the Knee
Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm
Active Comparator: Conventional PTA
Treatment with standard PTA
 Device: Standard PTA Control Arm
The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.


Outcome Measures
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Primary Outcome Measures :
  1. Primary patency to demonstrate that the 12-month primary patency for the DES BTK treatment group is superior to the PTA [ Time Frame: 12 months ]
    The primary effectiveness endpoint assesses primary patency using duplex ultrasound at 12 months post-procedure.

  2. Primary safety endpoint assesses major adverse events (MAE) at 12 months post-procedure [ Time Frame: 12 months ]
    The primary safety endpoint assesses major adverse events (MAE) at 12 months post-procedure.(MAE is defined as: above ankle amputation in index limb; major re-intervention; and perioperative (30 day) mortality


Other Outcome Measures:
  1. Primary and assisted primary patency [ Time Frame: 1,6,12, 24 and 36 months post procedure ]
    Target lesion patency rate measured by duplex ultrasound.

  2. Clinically driven target lesion revascularization [ Time Frame: 1, 3, 6, 12, 24 and 36 months post procedure ]
    Clinically-driven target lesion revascularization is any surgical or percutaneous intervention to the target lesion after the index procedure.

  3. Major amputation rates [ Time Frame: 1, 3, 6, 12, 24,and 36 months post procedure ]
    Rates of amputation of the lower limb at the ankle level or above

  4. Subject quality-of-life values by change in EQ-5D (EuroQol 5 dimension) [ Time Frame: 1, 3, 6 and 12 months post procedure ]
    The EQ-5D is a descriptive system of health-related quality-of-life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 5 responses. The responses record 5 levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension). The levels are assigned a numeric code 1-5 (eg, 1= no problems and 5= extreme problems). Sub-scores are not applicable.

  5. Subject quality-of-life values by change in VascuQol [ Time Frame: 1, 3, 6 and 12 months post procedure ]
    The VascuQol is a 25 item questionnaire used to measure the quality-of-life in patients with lower limb ischemia. The tool is sub-divided into 5 domains: pain, symptoms, activities, social and emotional. Each domain is scored 1-7 = the total of domain item scores divided by the number of questions in the domain. The total VascuQol score is also scored 1-7 = the total of all the item scores divided by 25.Sub-scores are not applicable.

  6. Wound Assessment [ Time Frame: 1, 3, 6, 12, 24, and 36 months post procedure ]
    Descriptive characteristics of wound healing will be recorded

  7. Rutherford classification [ Time Frame: 3, 6, 12, 24, and 36 months post procedure ]
    Change in Rutherford classification as assessed by the investigator

  8. Adverse Events [ Time Frame: 1, 3, 6, 12, 24, and 36 months post procedure ]
    Adverse events (AEs) (to be classified as major, serious, non-serious, unanticipated, procedure-related and device-related)

  9. 30-day unplanned hospital readmission rate [ Time Frame: Up to 30 days post procedure ]
    Hospitalizations related to Critical Limb Ischemia

  10. Survival rate at 4 years and 5 years post-procedure [ Time Frame: 4 and 5 years post procedure ]
    Telephone follow-up visit and/or medical chart review and/or publicly available records consultation for vital status

  11. Hemodynamic outcomes [ Time Frame: 6 and 12 months post procedure ]
    Changes in ABI and/or TBI


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is 18 years or older and has signed and dated the trial informed consent form (ICF)
  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).
  2. Target lesion(s) must be at least 4cm above the ankle joint
  3. A single target lesion per vessel, in up to 2 vessels, in a single limb
  4. Degree of stenosis ≥ 70% by visual angiographic assessment
  5. Reference vessel diameter is between 2.5 - 3.25mm for phase A RCT
  6. RVD is between 2.5 - 3.75mm for phase B non-randomized (Note: RVD is dependent on stent size being used. Refer to DFU for specific requirements)
  7. Total target lesion length (or series of lesion segments) to be treated is ≤ 70 mm for phase A RCT prior to the data monitoring committee's approval for stent overlap. (Note: Lesion segment(s) must be fully covered with one DES BTK stent, if randomized to stent)
  8. Total target lesion length (or series of lesion segments) to be treated is ≤ 140 mm for phase A RCT after the data monitoring committee's approval for stent overlap (Note: Lesion segment(s) must be fully covered with up to two DES BTK stents, if randomized to stent)
  9. Total target lesion length (or series of lesion segments) to be treated is ≤ 140 mm for phase B non-randomized (Note: Lesion segment(s) must be fully covered with up to two DES BTK stents)
  10. Target vessel(s) reconstitute(s) at or above the stenting limit zone (4cm above the ankle joint)
  11. Target lesion(s) is located in an area that may be stented without blocking access to patent main branches
  12. Treatment of all above the knee inflow lesion(s) is successful prior to treatment of the target lesion
  13. Guidewire has successfully crossed the target lesion(s)

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 bypass)
  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03551496


Locations
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Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Jihad Mustapha, MD Advanced Cardiac & Vascular Centers for Amputation Prevention
Principal Investigator: Hendrik van Overhagen, MD HAGA Ziekenhuis (HagaZiekenhuis van Den Haag)
Principal Investigator: Patrick Geraghty, MD Washington University School of Medicine
Principal Investigator: Masato Nakamura, MD, PhD Toho University Ohashi Medical Center - Division of Cardiovascular Medicine
More Information
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Publications:

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT03551496    
Other Study ID Numbers: S2348
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: March 21, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes