Your session is about to expire
← Back to Search
Drug Eluting Stent
Drug-Eluting Stent vs PTA for Critical Limb Ischemia (SAVAL Trial)
Phase 3
Waitlist Available
Led By Masato Nakamura, MD, PhD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Reference vessel diameter is between 2.5 - 3.25mm for phase A RCT
Stenotic, restenotic or occlusive target lesion(s) located in the tibioperoneal trunk, anterior tibial, posterior tibial and/or peroneal artery(ies)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
SAVAL Trial Summary
This trial is designed to show that the DES BTK Vascular Stent System is better than PTA at keeping the arteries open and is safe to use.
Who is the study for?
This trial is for adults with critical limb ischemia, specifically in the lower limbs, who have a vessel diameter of 2.5 - 3.25mm and lesion length ≤70 mm (up to 140 mm after approval). Participants must not be pregnant, should agree to birth control if applicable, and be able to follow the trial procedures. Exclusions include life expectancy ≤1 year, recent stroke or major amputation, certain diseases like Buerger's disease or vasculitis, severe allergies to stent materials or contrast media that can't be pre-medicated.Check my eligibility
What is being tested?
The study compares two treatments for below-the-knee artery lesions: a new Drug Eluting Stent (DES) system versus standard percutaneous transluminal angioplasty (PTA). The goal is to see if the DES provides better blood flow patency while being safe.See study design
What are the potential side effects?
Potential side effects may include reactions at the stent placement site such as pain or bleeding, allergic reactions to stent materials or medications used during the procedure like antiplatelet therapy. There could also be risks associated with angioplasty such as blood vessel damage.
SAVAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood vessel size fits the required range for the study.
Select...
I have a narrowed or blocked artery in my lower leg.
Select...
I am over 18 and have signed the consent form for the trial.
Select...
I have one affected area in up to two blood vessels in one of my limbs.
Select...
My target blood vessel is above the specified area near my ankle.
Select...
A guidewire was successfully used to cross my lesion.
Select...
I have severe leg pain due to poor blood flow, with wounds on my toes or forefoot.
Select...
I've had successful treatment for conditions above my knee before treating my main issue.
Select...
The total length of my lesion to be treated is 70 mm or less.
Select...
My target lesion is higher than 4cm above my ankle.
SAVAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants Free From Major Adverse Events (MAE)
Number of Participants With Primary Patency
Other outcome measures
Number of Participants Who Were Admitted to the Hospital Within 30 Days After the Index Procedure.
Number of Participants With Assisted Primary Patency
Number of Participants With Baseline Wounds Assessed as Healed
+7 moreSAVAL Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DES BTKExperimental Treatment1 Intervention
Treatment with DES BTK
Group II: Conventional PTAActive Control1 Intervention
Treatment with standard PTA
Find a Location
Who is running the clinical trial?
Boston Scientific CorporationLead Sponsor
719 Previous Clinical Trials
933,197 Total Patients Enrolled
Masato Nakamura, MD, PhDPrincipal InvestigatorToho University Ohashi Medical Center - Division of Cardiovascular Medicine
Jihad Mustapha, MDPrincipal InvestigatorAdvanced Cardiac & Vascular Centers for Amputation Prevention
8 Previous Clinical Trials
2,802 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood vessel size fits the required range for the study.You have had a stent placed in the specific blood vessels being studied.Your platelet count was too low or too high in the 30 days before the procedure.I have heart problems that cause chest pain.My blood vessel blockage is not due to hardening of the arteries.You are not expected to live more than one year.I have a narrowed or blocked artery in my lower leg.I am currently taking high doses of steroids or immunosuppressive medication.You have very calcified (hardened with calcium) lesions.I am over 18 and have signed the consent form for the trial.I have a blood clotting disorder.I cannot take blood thinners or medications that prevent blood clots.I have a blood clot or blockage in my arteries shown by an imaging test.I need treatment in more than two blood vessels.I am a man or a woman not currently pregnant. If I can have children, I use or agree to use birth control.I have one affected area in up to two blood vessels in one of my limbs.The total length of my lesion to be treated is 140 mm or less.My target blood vessel is above the specified area near my ankle.I have had a stroke within the last 3 months.I have had or will have a major amputation in one of my limbs.I have had surgery before on the blood vessel we are looking at.I have severe leg pain due to poor blood flow, with wounds on my toes or forefoot.My target lesion can be treated with a stent without blocking major branches.I've had successful treatment for conditions above my knee before treating my main issue.A guidewire was successfully used to cross my lesion.My treatment involves special procedures for my blood vessels.I have severe heart failure.The total length of my lesion to be treated is 70 mm or less.I am currently taking Canagliflozin.You are allergic to contrast dye and cannot take medicine to prevent a reaction before a procedure.Your blood vessel is blocked by 70% or more, as seen on an angiogram.You have a very low body weight for your height.You are allergic to heparin.My kidney function is very low, with a GFR of 30 or less.I currently have an active blood infection.You have had a failed procedure to open up a blocked blood vessel within the past 60 days.I have not had a heart attack or clot treatment in the last 3 months.My target lesion is higher than 4cm above my ankle.I have an aneurysm in my blood vessel.
Research Study Groups:
This trial has the following groups:- Group 1: DES BTK
- Group 2: Conventional PTA
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any risks associated with using a Drug Eluting Stent - Below the Knee?
"A Drug Eluting Stent - Below the Knee Phase 3 trial exists, which provides some evidence of efficacy. There is also multiple rounds of data which support safety; thus, we rate the safety a 3."
Answered by AI
Could you please give me an estimate of how many different areas this trial is taking place in?
"There are presently 28 sites running this clinical trial, with locations in Houston, Saint Paul, San Francisco and 25 other cities. It is important to choose the clinic closest to your location to reduce travel time and costs if you enroll."
Answered by AI
Does this clinical trial have any open slots for new patients?
"The clinical trial in question is not enrolling new patients at this time, as last seen on clinicaltrials.gov. However, there are 414 other trials with open recruitment at the moment."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger