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



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:August 31, 2018
End Date:May 2024
Contact:Lieve Cornelis
Email:Lieve.Cornelis@bsci.com
Phone:+32.476.840.183

Use our guide to learn which trials are right for you!

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

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).

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. Assuming the effectiveness endpoint is met in 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.

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

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 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 using the
assigned/randomized therapy

4. Degree of stenosis ≥ 70% by visual angiographic assessment

5. Reference vessel diameter is between 2.5 - 3.75mm

6. Total target lesion length to be treated is ≤ 70mm for phase A RCT prior to the data
monitoring committee's approval for stent overlap

7. Total target lesion length to be treated is ≤ 140 mm for phase A RCT after the data
monitoring committee's approval for stent overlap

8. Total target lesion length to be treated is ≤ 140 mm for phase B non-randomized

9. Target vessel(s) reconstitute(s) at or above the stenting limit zone (4cm above the
ankle joint)

10. Target lesion is located in an area that may be stented without blocking access to
patent main branches

11. Treatment of all above the knee inflow lesion(s) is successful prior to treatment of
the target lesion

12. Guidewire has successfully crossed the target lesion

Exclusion Criteria:

1. Life expectancy ≤ 1year

2. Stroke ≤ 90 days prior to date the subject signed the ICF

3. Prior or planned major amputation in the target limb

4. Previous surgery in the target vessel (including prior ipsilateral crural bypass)

5. Previously implanted stent in the target vessel(s) to be treated

6. Failed PTA of target lesion/vessel ≤ 60 days prior to date the subject signed the ICF

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 less than or equal to 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 date the subject
signed the ICF

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 requires the use of alternate therapy in the target vessel(s)/lesion(s),
(eg, atherectomy, cutting balloon, re-entry devices, laser, radiation therapy)

3. Aneurysm is present in the target vessel(s)

4. Extremely calcified lesions
We found this trial at
32
sites
Lubbock, Texas 79430
Principal Investigator: Mohammad Ansari, MD
Phone: 806-743-6900
?
mi
from
Lubbock, TX
Click here to add this to my saved trials
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Marc Schermerhorn, MD
Phone: 617-632-9971
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Sean Lyden, MD
Phone: 440-666-5335
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Principal Investigator: Miguel Montero-Baker, MD
Phone: 713-798-7536
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Principal Investigator: Mona Ranade, MD
Phone: 212-241-8333
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
?
mi
from
New York, NY
Click here to add this to my saved trials
Albuquerque, New Mexico 87102
Principal Investigator: Steve (Esteban) Henao, MD
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Atlantis, Florida 33462
Principal Investigator: Paul Michael, MD
Phone: 561-793-6100
?
mi
from
Atlantis, FL
Click here to add this to my saved trials
Bossier City, Louisiana 71111
Principal Investigator: William Eaves, MD
?
mi
from
Bossier City, LA
Click here to add this to my saved trials
Bradenton, Florida 34205
Principal Investigator: Jay Mathews, MD
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
3535 Olentangy River Road
Columbus, Ohio 43214
Principal Investigator: John Phillips, MD
Phone: 614-566-1250
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Dendermonde,
Principal Investigator: Koen Deloose, MD
Phone: 32 52 25 25 17
?
mi
from
Dendermonde,
Click here to add this to my saved trials
Denver, Colorado 80220
Principal Investigator: Ehrin Armstrong, MD
?
mi
from
Denver, CO
Click here to add this to my saved trials
Erie, Pennsylvania 16544
Principal Investigator: Matthew Becker, MD
?
mi
from
Erie, PA
Click here to add this to my saved trials
Grand Rapids, Michigan 49525
Principal Investigator: Jihad Mustapha, MD
Phone: 616-391-3998
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: David O'Connor, MD
Phone: 201-343-0040
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
Houma, Louisiana 70360
Principal Investigator: Craig Walker, MD
Phone: 985-855-4841
?
mi
from
Houma, LA
Click here to add this to my saved trials
Jackson, Tennessee 38305
Principal Investigator: Greg Bruno, MD
?
mi
from
Jackson, TN
Click here to add this to my saved trials
Jonesboro, Arkansas 72401
Principal Investigator: Max Arroyo, MD
?
mi
from
Jonesboro, AR
Click here to add this to my saved trials
Little Rock, Arkansas 72211
Principal Investigator: Ian Cawich, MD
Phone: 501-614-3643
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Los Angeles, California 90033
Principal Investigator: Leonardo Clavejo, MD
Phone: 626-319-6577
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
8900 N Kendall Dr
Miami, Florida 33176
(786) 596-1960
Principal Investigator: Constantino Pena, MD
Phone: 786-596-5991
Baptist Hospital of Miami Since 1960, Baptist Hospital of Miami has been one of the...
?
mi
from
Miami, FL
Click here to add this to my saved trials
Milwaukee, Wisconsin 53211
Principal Investigator: Erik Stilp, MD
Phone: 414-298-7230
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Nashville, Tennessee 37203
Principal Investigator: Bryan Fisher, MD
Phone: 615-329-7887
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Haven, Connecticut 06510
Principal Investigator: Carlos Mena-Hurtado, MD
Phone: 203-737-7673
?
mi
from
New Haven, CT
Click here to add this to my saved trials
New York, New York 10021
Principal Investigator: Anvar Babaev, MD
Phone: 917-607-7954
?
mi
from
New York, NY
Click here to add this to my saved trials
Oklahoma City, Oklahoma
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
6200 West Parker Road
Plano, Texas 75093
Principal Investigator: Vijay Ramanath, MD
?
mi
from
Plano, TX
Click here to add this to my saved trials
Raleigh, North Carolina 27610
Principal Investigator: Siddhartha Rao, MD
Phone: 919-350-8317
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Patrick Geraghty, MD
Phone: 314-362-7408
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Paul, Minnesota 55102
Principal Investigator: Mark Fleming, MD
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials
Teaneck, New Jersey 07666
Principal Investigator: John Rundback, MD
Phone: 201-833-3000
?
mi
from
Teaneck, NJ
Click here to add this to my saved trials
West Des Moines, Iowa 50266
Principal Investigator: Eric Scott, MD
Phone: 515-875-9090
?
mi
from
West Des Moines, IA
Click here to add this to my saved trials