The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia

Phase 3

Completed

• Conditions: Critical Limb Ischemia
• Interventions: Combination Product: Drug Eluting Stent - Below the Knee; Device: Standard PTA Control Arm

• Registration Number: NCT03551496
• Lead Sponsor: Boston Scientific Corporation

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.

Study Timeline

• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-06-07
• Study First Posted: 2018-06-11
• Study Start: 2018-08-31
• Primary Completion: 2022-04-21
• Results First Submitted: 2023-04-21
• Results First Submitted QC: 2023-07-20
• Results First Posted: 2023-08-14
• Study Completion: 2023-12-20
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DES BTK	Drug Eluting Stent - Below the Knee	Treatment with DES BTK
Conventional PTA	Standard PTA Control Arm	Treatment with standard PTA

Primary Outcome Measures

Name	Time	Method
Number of Participants With Primary Patency	12 months	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.
Number of Participants Free From Major Adverse Events (MAE)	12 months	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)

Trial Locations

Locations (42)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Arkansas Heart Hospital; 🇺🇸 Little Rock, Arkansas, United States

Bradenton Cardiology; 🇺🇸 Bradenton, Florida, United States

Advanced Cardiac & Vascular Centers for Amputation Prevention; 🇺🇸 Grand Rapids, Michigan, United States

Willis Knighton Bossier Medical Center - Grace Research, LLC; 🇺🇸 Bossier City, Louisiana, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

New Mexico Heart Institute, PA; 🇺🇸 Albuquerque, New Mexico, United States

New York University Medical Center; 🇺🇸 New York, New York, United States

United Heart and Vascular Clinic; 🇺🇸 Saint Paul, Minnesota, United States

Holy Name Medical Center; 🇺🇸 Teaneck, New Jersey, United States

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States

Amputation Prevention Center of North Carolina; 🇺🇸 Cary, North Carolina, United States

NC Heart and Vascular Research, LLC; 🇺🇸 Raleigh, North Carolina, United States

Wake Medical Center; 🇺🇸 Raleigh, North Carolina, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

OhioHealth Research and Innovation Institute - Riverside Methodist Hospital; 🇺🇸 Columbus, Ohio, United States

Saint Vincent Consultants in Cardiovascular Diseases at St. Vincent Hospital; 🇺🇸 Erie, Pennsylvania, United States

Texas Tech University Health; 🇺🇸 Lubbock, Texas, United States

THR Presbyterian Plano; 🇺🇸 Plano, Texas, United States

Hopital Europeen Georges Pompidou; 🇫🇷 Paris, France

CHU Nantes; 🇫🇷 Nantes, France

Hopital Paris Saint Joseph; 🇫🇷 Paris, France

Asahikawa Medical University Hospital; 🇯🇵 Asahikawa-shi, Hokkaido, Japan

Clinique Pasteur; 🇫🇷 Toulouse, France

Kokura Memorial Hospital; 🇯🇵 Kitakyushu, Fukuoka, Japan

Kishiwada Tokushukai Hospital; 🇯🇵 Kishiwada, Osaka, Japan

HAGA Ziekenhuis (Haga Ziekenhuis van Den Haag); 🇳🇱 Den Haag, Netherlands

Tokyo Medical and Dental University, Medical Hospital; 🇯🇵 Bunkyō-Ku, Tokyo, Japan

Toho University Ohashi Medical Center; 🇯🇵 Meguro, Tokyo, Japan

ZOL Genk (Ziekenhuis Oost-Limburg); 🇧🇪 Genk, Belgium

UZ Gent (Universitair Ziekenhuis Gent); 🇧🇪 Gent, Belgium

Nara Medical University Hospital; 🇯🇵 Kashihara, Nara, Japan

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

St. Bernards Medical Center; 🇺🇸 Jonesboro, Arkansas, United States

AZ Sint-Blasius; 🇧🇪 Dendermonde, Belgium

Cardiovascular Institute of the South Clinical Research Corporation; 🇺🇸 Houma, Louisiana, United States

Jackson-Madison County General Hospital; 🇺🇸 Jackson, Tennessee, United States

Kansai Rosai Hospital; 🇯🇵 Amagasaki, Hyogo, Japan

Tokyo Bay Urayasu Ichikawa Medical Center; 🇯🇵 Urayasu-shi, Chiba-ken, Japan

Colorado VA; 🇺🇸 Denver, Colorado, United States

Integris Baptist Medical Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Heart Hospital of Austin; 🇺🇸 Austin, Texas, United States