Critical Limb Ischemia Clinical Trial
— SAVALOfficial 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
Verified date | May 2024 |
Source | Boston Scientific Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Single 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).
Status | Completed |
Enrollment | 201 |
Est. completion date | December 20, 2023 |
Est. primary completion date | April 21, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. 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) 7. 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) 8. Target vessel(s) reconstitute(s) at or above the stenting limit zone (4cm above the ankle joint) 9. Target lesion(s) is located in an area that may be stented without blocking access to patent main branches 10. Treatment of all above the knee inflow lesion(s) is successful prior to treatment of the target lesion 11. 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | AZ Sint-Blasius | Dendermonde | |
Belgium | ZOL Genk (Ziekenhuis Oost-Limburg) | Genk | |
Belgium | UZ Gent (Universitair Ziekenhuis Gent) | Gent | |
France | CHU Nantes | Nantes | |
France | Hopital Europeen Georges Pompidou | Paris | |
France | Hopital Paris Saint Joseph | Paris | |
France | Clinique Pasteur | Toulouse | |
Japan | Kansai Rosai Hospital | Amagasaki | Hyogo |
Japan | Asahikawa Medical University Hospital | Asahikawa-shi | Hokkaido |
Japan | Tokyo Medical and Dental University, Medical Hospital | Bunkyo-Ku | Tokyo |
Japan | Nara Medical University Hospital | Kashihara | Nara |
Japan | Kishiwada Tokushukai Hospital | Kishiwada | Osaka |
Japan | Kokura Memorial Hospital | Kitakyushu | Fukuoka |
Japan | Toho University Ohashi Medical Center | Meguro | Tokyo |
Japan | Tokyo Bay Urayasu Ichikawa Medical Center | Urayasu-shi | Chiba-ken |
Netherlands | HAGA Ziekenhuis (Haga Ziekenhuis van Den Haag) | Den Haag | |
United States | New Mexico Heart Institute, PA | Albuquerque | New Mexico |
United States | Heart Hospital of Austin | Austin | Texas |
United States | Willis Knighton Bossier Medical Center - Grace Research, LLC | Bossier City | Louisiana |
United States | Bradenton Cardiology | Bradenton | Florida |
United States | Amputation Prevention Center of North Carolina | Cary | North Carolina |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | OhioHealth Research and Innovation Institute - Riverside Methodist Hospital | Columbus | Ohio |
United States | Colorado VA | Denver | Colorado |
United States | Saint Vincent Consultants in Cardiovascular Diseases at St. Vincent Hospital | Erie | Pennsylvania |
United States | Advanced Cardiac & Vascular Centers for Amputation Prevention | Grand Rapids | Michigan |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Cardiovascular Institute of the South Clinical Research Corporation | Houma | Louisiana |
United States | Jackson-Madison County General Hospital | Jackson | Tennessee |
United States | St. Bernards Medical Center | Jonesboro | Arkansas |
United States | Arkansas Heart Hospital | Little Rock | Arkansas |
United States | Texas Tech University Health | Lubbock | Texas |
United States | Mount Sinai Medical Center | New York | New York |
United States | New York University Medical Center | New York | New York |
United States | Integris Baptist Medical Center | Oklahoma City | Oklahoma |
United States | THR Presbyterian Plano | Plano | Texas |
United States | NC Heart and Vascular Research, LLC | Raleigh | North Carolina |
United States | Wake Medical Center | Raleigh | North Carolina |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | United Heart and Vascular Clinic | Saint Paul | Minnesota |
United States | University of California, San Francisco | San Francisco | California |
United States | Holy Name Medical Center | Teaneck | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation |
United States, Belgium, France, Japan, Netherlands,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Participants With Assisted Primary Patency | Assisted primary patency defined as the percentage (%) of lesions without clinically-driven TLR and those with clinically-driven TLR (not due to complete occlusion or by-pass) which show flow by DUS without restenosis. | 12 months post procedure | |
Other | Number of Participants With Clinically Driven Target Lesion Revascularization | Clinically-driven target lesion revascularization is defined as any surgical or percutaneous intervention to the target lesion after the index procedure if:
Occurring within 5mm proximal or distal to the original treatment segment with diameter stenosis =50% by quantitative angiography and if participant has recurrent symptoms OR In-lesion diameter stenosis less than 50% might also be considered a MAE by the CEC if the subject has recurrent symptoms. Recurrent symptoms are defined as having = 1 change in Rutherford Classification or associated with decreased ABI/TBI of =20% or = 0.15 in the treated segment. |
12 months post procedure | |
Other | Number of Participants With Major Amputation (Defined as Amputation of the Lower Limb at the Ankle Level or Above) | Rates of amputation of the lower limb at the ankle level or above | 12 months post procedure | |
Other | Participant Quality-of-Life Changes Via EuroQol 5 Dimension (EQ-5D) Questionnaire. | 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). | 12 months post procedure | |
Other | Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire. | Changes in quality of life is measured using the Vascular Quality of Life (VascuQol) questionnaire, which 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. | 12 months post procedure | |
Other | Number of Participants With Baseline Wounds Assessed as Healed | Wounds assessed for healed status by Independent Wound Assessors, blinded to randomized treatment. | 12 months post procedure | |
Other | Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline | Endpoint determined to be a success when there is an improvement in Rutherford Classification of one or more categories as compared to pre-procedure without the need for repeat TLR. Rutherford Classifications:
i. Category 0 - Asymptomatic ii. Category 1 - Mild claudication iii. Category 2 - Moderate claudication iv. Category 3 - Severe claudication v. Category 4 - Ischemic rest pain vi. Category 5 - Minor tissue loss - nonhealing ulcer, focal gangrene vii. Category 6 - Major tissue loss - extending above transmetatarsal (TM) level |
12 months post procedure | |
Other | Number of Participants With Major, Serious, Non-serious, Unanticipated, Device-related and Procedure-related Adverse Events | Adverse events (AEs) to be classified as major (defined as above ankle amputation of the index limb, major re-intervention (new bypass graft, jump/interposition graft, or thrombectomy/thrombolysis) and perioperative (30 day) mortality), serious, non-serious, unanticipated, procedure-related and device-related. | 12 months post procedure | |
Other | Number of Participants Who Were Admitted to the Hospital Within 30 Days After the Index Procedure. | Hospitalizations related to Critical Limb Ischemia (CLI) due to target lesion revascularization (TLR)/target vessel revascularization (TVR) or Target Limb Major Amputation or Procedure/Device related Adverse Events | Up to 30 days post procedure | |
Other | Number of Participants With Hemodynamic Improvement | Hemodynamic improvement is defined as improvement of ankle-brachial index (ABI) by =0.10 or to an ABI =0.90 as compared to pre-procedure value without the need for repeat revascularization. | 12 months post procedure | |
Primary | Number of Participants With Primary Patency | Twelve-Month Primary Patency defined as a binary endpoint to be determined via duplex ultrasound (DUS) measuring flow at the 12-month follow-up visit, in the absence of clinically-driven target lesion revascularization (TLR) or bypass of the target lesion. Data table consists of the number of participants with flow as assessed by DUS. | 12 months | |
Primary | Number of Participants Free From Major Adverse Events (MAE) | The primary safety endpoint assesses freedom from 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) | 12 months |
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