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List of Clinical Studies

  201-541-6312    |      clinicalresearch@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).
Read more.
John Rundback, MD
LIFE-BTK – Pivotal Investigation of Safety and Efficacy of BRS Treatment (Below the Knee) Randomized Controlled Trial.
Read more.
John Rundback, MD
CP-007 – A Prospective, Single-Arm Multicenter Study of the Bare Temporary Spur Stent System for the Treatment of Vascular Lesions located in the Infrapopliteal Arteries Below the Knee (DEEPER REVEAL).
Read more.
John Rundback, MD
MOTIV-BTK-RCT – A Prospective, Multicenter, Single Blind, Randomized Controlled Trial Evaluation the Safety and Effectiveness of the MOTIV Sirolimus-Eluting Bioresorbable Vascular Scaffold Compared with Plain Balloon Angioplasty for the Treatment of Infrapopliteal Lesions.
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).
Read more.
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.PACTAdmiral DCB.
Read more.
John Rundback, MD
OSPREY ILIAC – TIS2015-01 – Occlusive/Stenotic Peripheral artery Revascularization Study for Common and/or External Iliac Artery Using the Misago® RX Self-expanding Peripheral Stent.
Read more.
John Rundback, MD
DEFIANCE 22-001 – RCT of ClotTriever® System vs. Anticoagluation in deep vein thrombosis.
Read more.
John Rundback, MD
SELUTION4SFA – A Prospective Randomized Multicenter Single-Blinded Study to Assess the Safety and Efficacy of the SELUTION SLR™ 018 Drug Eluting Balloon in the Treatment of Subjects with Femopopliteal Artery Lesions.
Read more.
John Rundback, MD

Vascular - Venous Insufficiency

Study Name Principal Investigator
Vesper V-CA-001 – Venous Stent for the Iliofemoral Vein Investigational Clinical Trial Using the DUO Venous Stent System (VIVID)
Read more.
John Rundback, MD