Clinical trial NCT03551496: The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Critical Limb Ischemia
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2018-06-11
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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).

Approximately 201 subjects will be randomized/enrolled to support a 2:1 randomization.

Eligibility 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. 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

Primary outcomes:
measure: Number of Participants With Primary Patency
timeFrame: 12 months
measure: Number of Participants Free From Major Adverse Events (MAE)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Number of Participants With Assisted Primary Patency
timeFrame: 12 months post procedure
measure: Number of Participants With Clinically Driven Target Lesion Revascularization
timeFrame: 12 months post procedure
measure: Number of Participants With Major Amputation (Defined as Amputation of the Lower Limb at the Ankle Level or Above)
timeFrame: 12 months post procedure
measure: Participant Quality-of-Life Changes Via EuroQol 5 Dimension (EQ-5D) Questionnaire.
timeFrame: 12 months post procedure
measure: Participant Quality-of-Life Changes Via Vascular Quality of Life (VascuQol) Questionnaire.
timeFrame: 12 months post procedure
measure: Number of Participants With Baseline Wounds Assessed as Healed
timeFrame: 12 months post procedure
measure: Number of Participants With Rate of Primary Sustained Clinical Improvement as Assessed by Changes in Rutherford Classification From Baseline
timeFrame: 12 months post procedure
measure: Number of Participants With Major, Serious, Non-serious, Unanticipated, Device-related and Procedure-related Adverse Events
timeFrame: 12 months post procedure
measure: Number of Participants Who Were Admitted to the Hospital Within 30 Days After the Index Procedure.
timeFrame: Up to 30 days post procedure
measure: Number of Participants With Hemodynamic Improvement
timeFrame: 12 months post procedure
Locations:
city: Jonesboro
country: United States
facility: St. Bernards Medical Center
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Denver
country: United States
facility: Colorado VA
state: Colorado
city: Bradenton
country: United States
facility: Bradenton Cardiology
state: Florida
city: Bossier City
country: United States
facility: Willis Knighton Bossier Medical Center - Grace Research, LLC
state: Louisiana
city: Houma
country: United States
facility: Cardiovascular Institute of the South Clinical Research Corporation
state: Louisiana
city: Grand Rapids
country: United States
facility: Advanced Cardiac & Vascular Centers for Amputation Prevention
state: Michigan
city: Saint Paul
country: United States
facility: United Heart and Vascular Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute, PA
state: New Mexico
city: New York
country: United States
facility: New York University Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Cary
country: United States
facility: Amputation Prevention Center of North Carolina
state: North Carolina
city: Raleigh
country: United States
facility: NC Heart and Vascular Research, LLC
state: North Carolina
city: Raleigh
country: United States
facility: Wake Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center
state: Oklahoma
city: Erie
country: United States
facility: Saint Vincent Consultants in Cardiovascular Diseases at St. Vincent Hospital
state: Pennsylvania
city: Jackson
country: United States
facility: Jackson-Madison County General Hospital
state: Tennessee
city: Austin
country: United States
facility: Heart Hospital of Austin
state: Texas
city: Lubbock
country: United States
facility: Texas Tech University Health
state: Texas
city: Plano
country: United States
facility: THR Presbyterian Plano
state: Texas
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius
city: Genk
country: Belgium
facility: ZOL Genk (Ziekenhuis Oost-Limburg)
city: Gent
country: Belgium
facility: UZ Gent (Universitair Ziekenhuis Gent)
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: Hopital Paris Saint Joseph
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Toulouse
country: France
facility: Clinique Pasteur
city: Urayasu-shi
country: Japan
facility: Tokyo Bay Urayasu Ichikawa Medical Center
state: Chiba-ken
city: Kitakyushu
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Asahikawa-shi
country: Japan
facility: Asahikawa Medical University Hospital
state: Hokkaido
city: Amagasaki
country: Japan
facility: Kansai Rosai Hospital
state: Hyogo
city: Kashihara
country: Japan
facility: Nara Medical University Hospital
state: Nara
city: Kishiwada
country: Japan
facility: Kishiwada Tokushukai Hospital
state: Osaka
city: Bunkyō-Ku
country: Japan
facility: Tokyo Medical and Dental University, Medical Hospital
state: Tokyo
city: Meguro
country: Japan
facility: Toho University Ohashi Medical Center
state: Tokyo
city: Den Haag
country: Netherlands
facility: HAGA Ziekenhuis (Haga Ziekenhuis van Den Haag)
Study officials:
affiliation: Advanced Cardiac & Vascular Centers for Amputation Prevention
name: Jihad Mustapha, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HAGA Ziekenhuis (HagaZiekenhuis van Den Haag)
name: Hendrik van Overhagen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Patrick Geraghty, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toho University Ohashi Medical Center - Division of Cardiovascular Medicine
name: Masato Nakamura, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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