UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033656 |
|---|---|
| Receipt number | R000038350 |
| Scientific 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 |
| Date of disclosure of the study information | 2018/08/10 |
| Last modified on | 2024/02/14 10:51:31 |
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Basic information
Public 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
Acronym
The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia
Scientific 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
Scientific Title:Acronym
The SAVAL Pivotal Trial
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 12-month primary patency for the DES BTK treatment group is superior to the PTA
The primary patency is determined via duplex ultrasound at the 12 months post-procedure.
Primary safety endpoint assesses major adverse events (MAE) at the 12 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 [ 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 ]
- 30-day unplanned hospital readmission rate [ Time Frame: Up to 30 days post procedure]
- Survival rate at 4 years and 5 years post-procedure [Time Frame: 4 and 5 years post procedure]
- Hemodynamic outcomes [ Time Frame: 6 and12 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 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:
1. Stenotic, restenotic or occlusive target lesion(s) located in the tibioperoneal trunk, anterior tibial, posterior tibial and/or peroneal artery(ies).
- Target lesion(s) must be at least 4cm above the ankle joint
- A single target lesion per vessel, in up to 2 vessels, in a single limb
- Degree of stenosis => 70% by visual angiographic assessment
- Reference vessel diameter (RVD) is between 2.5 - 3.25mm for phase A RCT
RVD is between 2.5 - 3.75mm for phase B non-randomized
- Total target lesion length (or series of lesion segments) to be treated is <= 70mm for phase A RCT prior to the data monitoring committee's approval for stent overlap
- 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
- Total target lesion length (or series of lesion segments) 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(s) 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(s)
Key exclusion criteria
Pre-procedure:
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 1.73m^2, measured <= 30 days prior to the procedure date
8. Subject has a platelet count <= 50 or => 600 X 10^3/uL <= 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
Intra-procedure:
1. Angiographic evidence of intra-arterial acute/subacute thrombus or presence of atheroembolism
2. Treatment required in > 2 target vessels
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
Target sample size
201
Research contact person
Name of lead principal investigator
| 1st name | Jihad |
| Middle name | |
| Last name | Mustapha |
Organization
Advanced Cardiac & Vascular Amputation Prevention Center
Division name
Peripheral Intervention
Zip code
49525
Address
1525 E. Beltline, NE Suite 101, Grand Rapids, MI 49525
TEL
+1-616-447-8220
jihadmustapha@aol.com
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Kato |
Organization
Boston Scientific Japan K.K.
Division name
Clinical Sciences
Zip code
164-0001
Address
4-10-2 Nakano, Nakano-ku, Tokyo, Japan
TEL
03-6853-7500
Homepage URL
JapanClinicalTrials@bsci.com
Sponsor or person
Institute
Boston Scientific Japan K.K.
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Tokushukai Group Institutional Review Board
Address
1-3-1 Kudanminami, Chiyoda-ku, Tokyo
Tel
03-3263-4801
irb@mirai-iryo.com
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://journals.sagepub.com/doi/full/10.1177/1358863X231199489
Number of participants that the trial has enrolled
201
Results
A total of 201 patients were enrolled and randomly assigned to treatment (N = 130 DES, N = 71 PTA). Target lesion length was 68.1 +- 35.2 mm for the DES group and 68.7 +- 49.2 mm for the PTA group, and 31.0% and 27.6% of patients, respectively, had occlusions. The 12-month primary patency rates were 68.0% for the DES group and 76.0% for the PTA group (Psuperiority = 0.8552). The MAE-free rates were 91.6% and 95.3%, respectively (Pnoninferiority = 0.0433).
Results date posted
| 2024 | Year | 02 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 10 | Month | 16 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 07 | Day |
Last modified on
| 2024 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038350
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| Registered date | File name |
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