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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033656
Receipt No. R000038350
Official scientific title of the study 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
Date of disclosure of the study information 2018/08/10
Last modified on 2018/10/16

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Basic information
Official scientific title of the study 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
Title of the study (Brief title) The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia
Region
Japan North America Europe

Condition
Condition Critical Limb Ischemia
Classification by specialty
Cardiology Vascular surgery Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Primary patency to demonstrate that the 6-month primary patency for the DES BTK treatment group is superior to the PTA [ Time Frame: 6 months ]
The primary effectiveness endpoint assesses primary patency using duplex ultrasound at 6 months post-procedure.

Primary safety endpoint assesses major adverse events (MAE) at 6 months post-procedure [ Time Frame: 6 months ]
The primary safety endpoint assesses major adverse events (MAE) at 6 months post-procedure.(MAE is defined as: above ankle amputation in index limb; major re-intervention; and perioperative (30 day) mortality
Key secondary outcomes - Primary and assisted primary patency [ Time Frame: 1,6,12, 24 and 36 months post procedure ]
- Clinically driven target lesion revascularization [ Time Frame: 1, 3, 6, 12, 24 and 36 months post procedure ]
- Major amputation rates [ Time Frame: 1, 3, 6, 12, 24,and 36 months post procedure ]
- Subject quality-of-life values by change in EQ-5D (EuroQol 5 dimension) [ Time Frame: 1, 3, 6 and 12 months post procedure ]
- Subject quality-of-life values by change in VascuQol [ Time Frame: 1, 3, 6 and 12 months post procedure ]
- Wound Assessment healing [ Time Frame: 1, 3, 6, 12, 24, and 36 months post procedure ]
- Rutherford classification [ Time Frame: 3, 6, 12, 24, and 36 months post procedure ]
- Adverse Events [ Time Frame: 1, 3, 6, 12, 24, and 36 months post procedure ]
- Wound Assessment infection [ Time Frame: 1, 3, 6, 12, 24, and 36 months post procedure ]

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Drug Eluting Stent - Below the Knee
Interventions/Control_2 Standard PTA
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Pre-procedure:
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:
1. Stenotic, restenotic or occlusive target lesion(s) located in the tibioperoneal trunk, anterior tibial, posterior tibial and/or peroneal artery(ies).
- Target lesion must be at least 4cm above the ankle joint
- A single target lesion per vessel, in up to 2 vessels, in a single limb using the assigned/randomized therapy
- Degree of stenosis => 70% by visual angiographic assessment
- Reference vessel diameter is between 2.5 - 3.75mm
- Total target lesion length to be treated is <= 70mm for phase A RCT prior to the data monitoring committee's approval for stent overlap
- Total target lesion length to be treated is <= 140 mm for phase A RCT after the data monitoring committee's approval for stent overlap
- Total target lesion length to be treated is <= 140 mm for phase B non-randomized
2. Target vessel(s) reconstitute(s) at or above the stenting limit zone (4cm above the ankle joint)
3. Target lesion is located in an area that may be stented without blocking access to patent main branches
4. Treatment of all above the knee inflow lesion(s) is successful prior to treatment of the target lesion
5. Guidewire has successfully crossed the target lesion
Key exclusion criteria Pre-procedure:
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 1.73m^2, measured <= 30 days prior to the procedure date
8. Subject has a platelet count <= 50 or => 600 X 10^3/uL 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

Intra-procedure:
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
Target sample size 201

Research contact person
Name of lead principal investigator Jihad Mustapha
Organization Advanced Cardiac & Vascular Amputation Prevention Center
Division name Peripheral Intervention
Address 1525 E. Beltline, NE Suite 101, Grand Rapids, MI 49525
TEL +1-616-447-8220
Email jihadmustapha@aol.com

Public contact
Name of contact person Hiroshi, SAKAMOTO
Organization Boston Scientific Japan K.K.
Division name Clinical Sciences
Address 4-10-2 Nakano, Nakano-ku, Tokyo, Japan
TEL 03-6853-7500
Homepage URL
Email Hiroshi.Sakamoto@bsci.com

Sponsor
Institute Boston Scientific Japan K.K.
Institute
Department

Funding Source
Organization Boston Scientific Japan K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs YES
Study ID_1 NCT03551496
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW 初回届出年月日: 2018年5月25日; 届出回数: 第1回

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 10 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 28 Day
Anticipated trial start date
2018 Year 08 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 07 Day
Last modified on
2018 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038350

Research Plan
Registered date File name

Research case data specifications
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Research case data
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