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List of Clinical Studies

  201-541-6312    |      info@holyname.org

Vascular - Critical Limb Ischemia (CLI)

Study Name Principal Investigator
SAVAL – A phase 3, 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).
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John Rundback, MD
Abbott LIFE-BTK – Pivotal Investigation of Safety and Efficacy of BRS Treatment (Below the Knee) Randomized Controlled Trial.
Read more.
John Rundback, MD

Vascular - Native Arteriovenous Dialysis Fistulae (AVF)

Study Name Principal Investigator
APV-IN.PACT AV Access - A randomized Study of IN.PACT™ AV Access Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon vs. Standard PTA for the Treatment of Obstructive Lesions in the Native Arteriovenous Dialysis Fistulae (AVF).
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Vincent Gallo, MD
TOBA II BTK – Tack Optimized Balloon Angioplasty study for the below the knee arteries using the Tack Endovascular System TM.
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John Rundback, MD

Vascular - Peripheral Artery Disease (PAD)

Study Name Principal Investigator
TRANSCEND – SurVeil™ Drug-Coated Balloon – A prospective, multi-center, single-blind, randomized, controlled, noninferiority clinical trial. The trial will randomize subjects with symptomatic PAD due to stenosis of the femoral and/or popliteal arteries. Subjects meeting eligibility criteria will be randomized 1:1 to treatment with either the SurVeil DCB or the IN.PACT Admiral DCB.
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John Rundback, MD

Vascular - Venous Insufficiency

Study Name Principal Investigator
ABRE– A multi-center, non-randomized study to evaluate the safety and effectiveness of the Abre venous self-expanding stent system in patients with symptomatic iliofemoral venous outflow obstruction.
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John Rundback, MD
Vesper V-CA-001 – Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System (VIVID)
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John Rundback, MD