The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia (SAVAL)
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|ClinicalTrials.gov Identifier: NCT03551496|
Recruitment Status : Active, not recruiting
First Posted : June 11, 2018
Last Update Posted : June 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Critical Limb Ischemia||Combination Product: Drug Eluting Stent - Below the Knee Device: Standard PTA Control Arm||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||301 participants|
|Intervention Model:||Parallel Assignment|
|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. Approximately 100 additional subjects will be enrolled in non-randomized phase B where the enrolled subjects are treated with the DES BTK.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||A review of the wound assessment data will be completed by an independent reviewer who will be blinded to the randomized therapy.|
|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|
|Actual Study Start Date :||August 31, 2018|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||November 30, 2027|
Experimental: DES BTK
Treatment with DES BTK
Combination Product: Drug Eluting Stent - Below the Knee
Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm
Active Comparator: Conventional PTA
Treatment with standard PTA
Device: Standard PTA Control Arm
The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.
- 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
- Primary and assisted primary patency [ Time Frame: 1,6,12, 24 and 36 months post procedure ]Target lesion patency rate measured by duplex ultrasound.
- Clinically driven target lesion revascularization [ Time Frame: 1, 3, 6, 12, 24 and 36 months post procedure ]Clinically-driven target lesion revascularization is any surgical or percutaneous intervention to the target lesion after the index procedure.
- Major amputation rates [ Time Frame: 1, 3, 6, 12, 24,and 36 months post procedure ]Rates of amputation of the lower limb at the ankle level or above
- Subject quality-of-life values by change in EQ-5D (EuroQol 5 dimension) [ Time Frame: 1, 3, 6 and 12 months post procedure ]The EQ-5D is a descriptive system of health-related quality-of-life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 5 responses. The responses record 5 levels of severity (no problems/slight problems/moderate problems/severe problems/extreme problems) within a particular EQ-5D dimension). The levels are assigned a numeric code 1-5 (eg, 1= no problems and 5= extreme problems). Sub-scores are not applicable.
- Subject quality-of-life values by change in VascuQol [ Time Frame: 1, 3, 6 and 12 months post procedure ]The VascuQol is a 25 item questionnaire used to measure the quality-of-life in patients with lower limb ischemia. The tool is sub-divided into 5 domains: pain, symptoms, activities, social and emotional. Each domain is scored 1-7 = the total of domain item scores divided by the number of questions in the domain. The total VascuQol score is also scored 1-7 = the total of all the item scores divided by 25.Sub-scores are not applicable.
- Wound Assessment [ Time Frame: 1, 3, 6, 12, 24, and 36 months post procedure ]Descriptive characteristics of wound healing will be recorded
- Rutherford classification [ Time Frame: 3, 6, 12, 24, and 36 months post procedure ]Change in Rutherford classification as assessed by the investigator
- Adverse Events [ Time Frame: 1, 3, 6, 12, 24, and 36 months post procedure ]Adverse events (AEs) (to be classified as major, serious, non-serious, unanticipated, procedure-related and device-related)
- 30-day unplanned hospital readmission rate [ Time Frame: Up to 30 days post procedure ]Hospitalizations related to Critical Limb Ischemia
- Survival rate at 4 years and 5 years post-procedure [ Time Frame: 4 and 5 years post procedure ]Telephone follow-up visit and/or medical chart review and/or publicly available records consultation for vital status
- Hemodynamic outcomes [ Time Frame: 6 and 12 months post procedure ]Changes in ABI and/or TBI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03551496
|Principal Investigator:||Jihad Mustapha, MD||Advanced Cardiac & Vascular Centers for Amputation Prevention|
|Principal Investigator:||Hendrik van Overhagen, MD||HAGA Ziekenhuis (HagaZiekenhuis van Den Haag)|
|Principal Investigator:||Patrick Geraghty, MD||Washington University School of Medicine|
|Principal Investigator:||Masato Nakamura, MD, PhD||Toho University Ohashi Medical Center - Division of Cardiovascular Medicine|