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Critical Limb IschemiaPhase 3SAVALNCT03551496

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

A Phase 3 study testing Drug Eluting Stent - Below the Knee in people with Critical Limb Ischemia, run by Boston Scientific Corporation at 42 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Single 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Critical Limb Ischemia
What is being tested?
Drug Eluting Stent - Below the Knee
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
201 participants
Where
42 sitesin 5 countries
Study dates
31 Aug 2018to 20 Dec 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is 18 years or older and has signed and dated the trial informed consent form (ICF)
  • Subject is willing and able to comply with the trial testing, procedures and follow-up schedule
  • 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
  • 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:
  • Stenotic, restenotic or occlusive target lesion(s) located in the tibioperoneal trunk, anterior tibial, posterior tibial and/or peroneal artery(ies).
Show all 16Show fewer
  • 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 is between 2.5 - 3.25mm for phase A RCT
  • Total target lesion length (or series of lesion segments) to be treated is ≤ 70 mm for phase A RCT prior to the data monitoring committee's approval for stent overlap. (Note: Lesion segment(s) must be fully covered with one DES BTK stent, if randomized to stent)
  • 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 (Note: Lesion segment(s) must be fully covered with up to two DES BTK stents, if randomized to stent)
  • Target vessel(s) reconstitute(s) at or above the stenting limit zone (4cm above the ankle joint)
  • Target lesion(s) is located in an area that may be stented without blocking access to patent main branches
  • Treatment of all above the knee inflow lesion(s) is successful prior to treatment of the target lesion
  • Guidewire has successfully crossed the target lesion(s)

Who cannot join

  • Life expectancy ≤ 1year
  • Stroke ≤ 90 days prior to the procedure date
  • Prior or planned major amputation in the target limb
  • Previous surgery in the target vessel(s) (including prior ipsilateral crural bypass)
  • Previously implanted stent in the target vessel(s)
  • Failed PTA of target lesion/vessel ≤ 60 days prior to the procedure date
Show all 28Show fewer
  • Renal failure as measured by a GFR ≤ 30ml/min per 1.73m2, measured ≤ 30 days prior to the procedure date
  • Subject has a platelet count ≤ 50 or ≥ 600 X 103/µL ≤ 30 days prior to the procedure date
  • NYHA class IV heart failure
  • Subject has symptomatic coronary artery disease (ie, unstable angina)
  • History of myocardial infarction or thrombolysis ≤ 90 days prior to the procedure date
  • Non-atherosclerotic disease resulting in occlusion (eg, embolism, Buerger's disease, vasculitis)
  • Subject is currently taking Canagliflozin
  • Body Mass Index (BMI) <18
  • Active septicemia or bacteremia
  • Coagulation disorder, including hypercoagulability
  • Contraindication to anticoagulation or antiplatelet therapy
  • Known allergies to stent or stent components
  • Known allergy to contrast media that cannot be adequately pre-medicated prior to the interventional procedure
  • Known hypersensitivity to heparin
  • Subject is on a high dose of steroids or is on immunosuppressive therapy
  • 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
  • Angiographic evidence of intra-arterial acute/subacute thrombus or presence of atheroembolism
  • Treatment required in > 2 target vessels (Note: a target lesion originating in one vessel and extending into another vessel is considered 1 target vessel)
  • Treatment requires the use of alternate therapy in the target vessel(s)/lesion(s), (eg, atherectomy, cutting balloon, re-entry devices, laser, radiation therapy)
  • Aneurysm is present in the target vessel(s)
  • Extremely calcified lesions

Trial locations and contacts

42 sites in 5 countries.

42 sites in 5 countries

United States26 sites

  • New Mexico Heart Institute, PA

    Albuquerque, New Mexico, 87102

  • Heart Hospital of Austin

    Austin, Texas, 78756

  • Willis Knighton Bossier Medical Center - Grace Research, LLC

    Bossier City, Louisiana, 71111

  • Bradenton Cardiology

    Bradenton, Florida, 34205

  • Amputation Prevention Center of North Carolina

    Cary, North Carolina, 27518

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • OhioHealth Research and Innovation Institute - Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Colorado VA

    Denver, Colorado, 80220

  • Saint Vincent Consultants in Cardiovascular Diseases at St. Vincent Hospital

    Erie, Pennsylvania, 16544

  • Advanced Cardiac & Vascular Centers for Amputation Prevention

    Grand Rapids, Michigan, 49525

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Cardiovascular Institute of the South Clinical Research Corporation

    Houma, Louisiana, 70360

  • Jackson-Madison County General Hospital

    Jackson, Tennessee, 38305

  • St. Bernards Medical Center

    Jonesboro, Arkansas, 72401

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • Texas Tech University Health

    Lubbock, Texas, 79430

  • New York University Medical Center

    New York, New York, 10016

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma, 73112

  • THR Presbyterian Plano

    Plano, Texas, 75093

  • NC Heart and Vascular Research, LLC

    Raleigh, North Carolina, 27607

  • Wake Medical Center

    Raleigh, North Carolina, 27610

  • United Heart and Vascular Clinic

    Saint Paul, Minnesota, 55102

  • University of California, San Francisco

    San Francisco, California, 94143

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666

Other trials in United States

Japan8 sites

  • Kansai Rosai Hospital

    Amagasaki, Hyōgo, 660-8511

  • Asahikawa Medical University Hospital

    Asahikawa-shi, Hokkaido, 078-8510

  • Tokyo Medical and Dental University, Medical Hospital

    Bunkyō-Ku, Tokyo, 113-8510

  • Nara Medical University Hospital

    Kashihara, Nara, 634-8522

  • Kishiwada Tokushukai Hospital

    Kishiwada, Osaka, 596-8522

  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka, 802-8555

  • Toho University Ohashi Medical Center

    Meguro City, Tokyo, 153-8515

  • Tokyo Bay Urayasu Ichikawa Medical Center

    Urayasu-shi, Chiba, 279-0001

Other trials in Japan

France4 sites

  • CHU Nantes

    Nantes, 44000

  • Hopital Paris Saint Joseph

    Paris, 75014

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Clinique Pasteur

    Toulouse, 31076

Other trials in France

Belgium3 sites

  • AZ Sint-Blasius

    Dendermonde, 9200

  • ZOL Genk (Ziekenhuis Oost-Limburg)

    Genk, 3600

  • UZ Gent (Universitair Ziekenhuis Gent)

    Ghent, 9000

Other trials in Belgium

Netherlands1 site

  • HAGA Ziekenhuis (Haga Ziekenhuis van Den Haag)

    The Hague, 2566

Other trials in Netherlands

About this study

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

Single 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).

Read the detailed description

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).

Approximately 201 subjects will be randomized/enrolled to support a 2:1 randomization.

Being tested
Drug Eluting Stent - Below the Knee, Standard PTA Control Arm
Medical subject headings
Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drug Eluting Stent - Below the KneeCombination product

    Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm

  • Standard PTA Control ArmDevice

    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.

Study groups in NCT03551496
Study groupRoleWhat they receive
DES BTKExperimentalTreatment with DES BTK
Receives: Combination Product: Drug Eluting Stent - Below the Knee
Conventional PTAActive comparatorTreatment with standard PTA
Receives: Device: Standard PTA Control Arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Primary Patency

    Twelve-Month Primary Patency defined as a binary endpoint to be determined via duplex ultrasound (DUS) measuring flow at the 12-month follow-up visit, in the absence of clinically-driven target lesion revascularization (TLR) or bypass of the target lesion. Data table consists of the number of participants with flow as assessed by DUS.

    Measured: 12 months

  2. Number of Participants Free From Major Adverse Events (MAE)

    The primary safety endpoint assesses freedom from major adverse events (MAE) at 12 months post-procedure. (MAE is defined as: above ankle amputation in index limb; major re-intervention; and perioperative (30 day) mortality)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2018
  2. Study start31 Aug 2018
  3. Primary completion21 Apr 2022
  4. Study completion20 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03551496
Sponsor's protocol ID
S2348
Acronym
SAVAL
Status last verified
Jun 2024
First submitted
15 May 2018
Last updated
1 Jul 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Kolte D, Kennedy KF, Shishehbor MH, Abbott JD, Khera S, Soukas P, Mamdani ST, Hyder ON, Drachman DE, Aronow HD. Thirty-Day Readmissions After Endovascular or Surgical Therapy for Critical Limb Ischemia: Analysis of the 2013 to 2014 Nationwide Readmissions Databases. Circulation. 2017 Jul 11;136(2):167-176. doi: 10.1161/CIRCULATIONAHA.117.027625. Epub 2017 May 2.

    PubMed 28465288

  • Conte MS, Geraghty PJ, Bradbury AW, Hevelone ND, Lipsitz SR, Moneta GL, Nehler MR, Powell RJ, Sidawy AN. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia. J Vasc Surg. 2009 Dec;50(6):1462-73.e1-3. doi: 10.1016/j.jvs.2009.09.044. Epub 2009 Nov 7.

    PubMed 19897335

  • Scheinert D, Katsanos K, Zeller T, Koppensteiner R, Commeau P, Bosiers M, Krankenberg H, Baumgartner I, Siablis D, Lammer J, Van Ransbeeck M, Qureshi AC, Stoll HP; ACHILLES Investigators. A prospective randomized multicenter comparison of balloon angioplasty and infrapopliteal stenting with the sirolimus-eluting stent in patients with ischemic peripheral arterial disease: 1-year results from the ACHILLES trial. J Am Coll Cardiol. 2012 Dec 4;60(22):2290-5. doi: 10.1016/j.jacc.2012.08.989.

    PubMed 23194941

  • Spreen MI, Martens JM, Hansen BE, Knippenberg B, Verhey E, van Dijk LC, de Vries JP, Vos JA, de Borst GJ, Vonken EJ, Wever JJ, Statius van Eps RG, Mali WP, van Overhagen H. Percutaneous Transluminal Angioplasty and Drug-Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia (PADI) Trial. Circ Cardiovasc Interv. 2016 Feb;9(2):e002376. doi: 10.1161/CIRCINTERVENTIONS.114.002376.

    PubMed 26861113

  • Kinlay S. Management of Critical Limb Ischemia. Circ Cardiovasc Interv. 2016 Feb;9(2):e001946. doi: 10.1161/CIRCINTERVENTIONS.115.001946.

    PubMed 26858079

  • Elsayed S, Clavijo LC. Critical limb ischemia. Cardiol Clin. 2015 Feb;33(1):37-47. doi: 10.1016/j.ccl.2014.09.008.

    PubMed 25439329

  • Conte MS. Critical appraisal of surgical revascularization for critical limb ischemia. J Vasc Surg. 2013 Feb;57(2 Suppl):8S-13S. doi: 10.1016/j.jvs.2012.05.114.

    PubMed 23336860

  • Gray BH, Diaz-Sandoval LJ, Dieter RS, Jaff MR, White CJ; Peripheral Vascular Disease Committee for the Society for Cardiovascular Angiography and Interventions. SCAI expert consensus statement for infrapopliteal arterial intervention appropriate use. Catheter Cardiovasc Interv. 2014 Oct 1;84(4):539-45. doi: 10.1002/ccd.25395. Epub 2014 Jul 18.

    PubMed 25045160

  • Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, Fowkes FG, Gillepsie I, Ruckley CV, Raab G, Storkey H; BASIL trial participants. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet. 2005 Dec 3;366(9501):1925-34. doi: 10.1016/S0140-6736(05)67704-5.

    PubMed 16325694

  • Popplewell MA, Davies HOB, Narayanswami J, Renton M, Sharp A, Bate G, Patel S, Deeks J, Bradbury AW. A Comparison of Outcomes in Patients with Infrapopliteal Disease Randomised to Vein Bypass or Plain Balloon Angioplasty in the Bypass vs. Angioplasty in Severe Ischaemia of the Leg (BASIL) Trial. Eur J Vasc Endovasc Surg. 2017 Aug;54(2):195-201. doi: 10.1016/j.ejvs.2017.04.020. Epub 2017 Jun 8.

    PubMed 28602580

  • Sadaghianloo N, Jean-Baptiste E, Declemy S, Mousnier A, Brizzi S, Hassen-Khodja R. Percutaneous angioplasty of long tibial occlusions in critical limb ischemia. Ann Vasc Surg. 2013 Oct;27(7):894-903. doi: 10.1016/j.avsg.2013.02.008.

    PubMed 23993107

  • Bosiers M, Scheinert D, Peeters P, Torsello G, Zeller T, Deloose K, Schmidt A, Tessarek J, Vinck E, Schwartz LB. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. J Vasc Surg. 2012 Feb;55(2):390-8. doi: 10.1016/j.jvs.2011.07.099. Epub 2011 Dec 14.

    PubMed 22169682

  • Spreen MI, Martens JM, Knippenberg B, van Dijk LC, de Vries JPM, Vos JA, de Borst GJ, Vonken EPA, Bijlstra OD, Wever JJ, Statius van Eps RG, Mali WPTM, van Overhagen H. Long-Term Follow-up of the PADI Trial: Percutaneous Transluminal Angioplasty Versus Drug-Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia. J Am Heart Assoc. 2017 Apr 14;6(4):e004877. doi: 10.1161/JAHA.116.004877.

    PubMed 28411244

  • de Weger VA, Beijnen JH, Schellens JH. Cellular and clinical pharmacology of the taxanes docetaxel and paclitaxel--a review. Anticancer Drugs. 2014 May;25(5):488-94. doi: 10.1097/CAD.0000000000000093.

    PubMed 24637579

  • Ng VG, Mena C, Pietras C, Lansky AJ. Local delivery of paclitaxel in the treatment of peripheral arterial disease. Eur J Clin Invest. 2015 Mar;45(3):333-45. doi: 10.1111/eci.12407. Epub 2015 Feb 14.

    PubMed 25615282

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Drug Eluting Stent - Below the Knee in people with Critical Limb Ischemia, run by Boston Scientific Corporation at 42 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, Japan, France, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Primary Patency (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03551496, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.

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