Endovascular and Peripheral Intervention

Overview

Endovascular and peripheral interventions are a rapidly evolving area of clinical research at Yale. Yale-New Haven Hospital performs over 500 invasive peripheral diagnostic procedures and more than 300 peripheral interventions annually.

Our physicians perform the full range of diagnostic and therapeutic procedures, including iliac, femoral, renal, carotid, subclavian, and aortic interventions. We employ the latest treatment and imaging modalities, including intravascular ultrasound, atherectomy, thrombectomy, distal protection, laser, crossing devices, and re-entry devices.

Current Research

Current endovascular and peripheral interventional research consists of the following ongoing and recent studies including investigations of:

Drug-coated/drug-eluting balloons

  • LEVANT 2 – A comparison of a drug-coated balloon with standard balloon angioplasty for the treatment of femoro-popliteal artery lesions
  • Lutonix BTK - A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Lutonix Drug Coated Ballon vs. Standard Balloon Angioplasty for Treatment of Below-the-Knee (BTK) Arteries. 
  • ILLUMENATE - Prospective, Randomized, Multi-Center, Single-Blind Study of the Treatment of Subjects Presenting with De Novo Occluded/Stenotic or Re-occluded/Restenotic Lesions of the Superficial Femoral or Popliteal Arteries Using a Paclitaxel-Coated or Bare Percutaneous Transluminal Angioplasty Balloon Catheter
  • Lutonix ISR - A Prospective, Multicenter, Single-Blind, Randomized, Controlled Trial Comparing the Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis

Peripheral stents

  • Bioflex-I Trial – IDE trial of two new stents to treat femoro-popliteal and iliac artery lesions
  • TIGRIS – Evaluation of a vascular stent in the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal arteries
  • OPEN - Evaluation of Safety and Efficacy of the FlexStent Femoropopliteal Self-Expanding Stent System Study
  • VIABAHN - Evaluation of the GORE VIABAHN BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX) for the treatment of Occlusive Disease in the Common and External Iliac Arteries
  • MIMICS- BioMimics 3D Stent Clinical Investigation: The Mimics Study

Peripheral Artery Disease

  • PORTRAIT -  Portrait Registry: Patient Oriented Outcomes Related to Treatment practices in Peripheral Arterial Disease: An International Trajectory
  • BEST CLI - Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb Ischemia

Peripheral stent grafts

  • Investigation of a novel polytetrafluoroethylene (PTFE) superficial femoral artery (SFA) stent graft
  • ASPECT- FDA-supported comparison of commercially available peripheral stents

Carotid stenting and embolic protection systems

  • CHOICE – Post market surveillance of carotid stent and embolic protection systems in high-risk surgical patients
  • SCAFFOLD - Gore Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis in Patients at Increased Risk for Adverse Events from Carotid Endarterectomy
  • CREST II - CAROTID REVASCULARIZATION AND MEDICAL MANAGEMENT FOR Asymptomatic Carotid Stenosis Trial

Transcatheter renal denervation therapy

  • Symplicity HTN-3 – Randomized trial of the safety and effectiveness of percutaneous renal denervation in subjects with uncontrolled hypertension

Arterial anatomy and erectile dysfunction (ED)

  • IMPASSE – A long-term observational study to determine the prevalence of angiographically-identifiable erectile-related artery atherosclerosis in men with known or suspected coronary or peripheral artery disease

Atherectomy

  • JET Registry – Postmarket surveillance registry of a combined-treatment catheter for the treatment of diffuse occlusive PAD

Invasive Modalities

  • EXCITE ISR - Excimer Laser Randomized Controlled Study for the Treatment of Femoropopliteal In-Stent Restenosis
  • LUMEN - The Lumen Study: A Prospective, Multicenter, Open Label Randomized Study to Evaluate the Safety, Performance and Intraluminal Crossing of the TruePath CTO Device versus The Crosser System in Patients with Symptomatic Femoro-popliteal Chronic Total Occlusion

Faculty

Bio Profile

Jeptha P Curtis

Associate Professor of Medicine (Cardiology)

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Carlos Ignacio Mena

Assistant Professor of Medicine (Cardiology)

Medical Director Vascular Medicine - YNHH

Bio Profile

Steven E Pfau

Associate Professor of Medicine (Cardiology)

Director, Cardiac Catheterization Laboratory, VA Connecticut

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Michael S Remetz

Associate Professor of Medicine (Cardiology)

Director, Goodyer Cardiology Teaching Firm

Medical Director