Clinical Trials Experience

Project Title

Role

Origin

Name Of Grant

Funding Agency

Project Date

Biolux-PIII Registry. Multicenter international registry for Femoral, popliteal, and below-the-knee arterial Passeo 18-Lux drug eluting balloon angioplasty. Singapore General Hospital.

P.I.

Germany, Multi-center, international registry

Biolux-PIII Global Registry

Biotronik AG

Oct 2015 –ongoing

Syngoiflow trial for hemodialysis vascular access interventions. Singapore General Hospital

Co-I

Singapore

N/A

Investigator initiated

N/A

Investigator initiated

Oct 2015 – present

REHEARSAAAL. Multicenter, randomized study to compare the clinical performance of AAA procedures with and without prior rehearsal in a virtual environment using the Symbionix Procedure Rehearsal Studio. University Hospitals Case Medical Center, Cleveland, OH.

P.I.

USA

Symbionix Educational Research Fund

Symbionix

Jun 2013 – Nov 2016

Evaluation of MST-188 (purified poloxamer 188) in Acute Limb Ischemia. A phase 2 randomized, double blind, placebo-controlled, multi-center clinical trial evaluating the safety and efficacy of ANX-188 in subjects with acute lower limb ischemia receiving catheter-directed recombinant tissue Plasminogen Activator. University Hospitals Case Medical Center, Cleveland, OH.

P.I.

USA

N/A

Mast Therapeutics, Inc.

Mar 2013 – Dec 2015

Effect of endovascular simulator practice on surgical trainees in proficiency and efficacy of endovascular skill, utilizing the Symbionixendosimulator system. University Hospitals Case Medical Center, Cleveland, OH.

P.I.

USA

N/A

Investigator initiated

Symbionix (endovascular simulator)

Jan 2014 – Dec 2014

Timing of Vein Mapping for Hemodialysis Arteriovenous Fistula Access Study. University Hospitals Case Medical Center, Cleveland, OH.

P.I.

USA

N/A

Investigator initiated

N/A

Investigator initiated

Sep 2012 – Oct 2014

PRICE – Propaten Randomized Investigation on Cost-benefit and Efficacy.  A randomized controlled comparative study on efficacy and cost-effectiveness of heparin-bonded versus non-heparin-bonded polytetrafluroethylene hemodialysis access grafts, University Hospitals Case Medical Center, Cleveland, OH.

Co-I

USA

N/A

Investigator initiated

N/A

Investigator initiated

May 2013 – Dec 2015

Biomet CLI. MarrowStim™ PAD Kit for the Treatment of Critical Limb Ischemia (CLI) in Subjects with Severe Peripheral Arterial Disease (PAD). Multicenter randomized prospective clinical trial. University Hospitals Case Medical Center, Cleveland, OH.

Co-I

USA

N/A

Biomet Biologics, LLC

Mar 2012 – Dec 2016

INSPIRATION. A Multicenter, Open Label, Prospective, Non-Randomized Study Of The INCRAFT™ Stent Graft System In Subjects With Abdominal Aortic Aneurysms, University Hospitals Case Medical Center, Cleveland, OH.

Co-I

USA

N/A

Cordis Corporation

Aug 2012

SIMPLICITY HTN-3. Renal Denervation in Patients with Uncontrolled Hypertension. Randomized prospective clinical trial, University Hospitals Case Medical Center, Cleveland, OH.

Co-I

USA

N/A

University of Erlangen-Nürnberg Medical School

Nov 2013

Carotid Revascularization with ev3 Arterial Technology Evolution Post Approval Study (CREATE-PAS). University Hospitals Case Medical Center, Cleveland, OH.

Co-I

USA

N/A

Medtronic Endovascular

Jun 2012 – Sep 2015

Biomimetic Vascular Prosthesis Engineering: Hybridization of PTFE graft to bioprosthetic graft with biological cell culture, in porcine carotid model. University Hospitals Case Medical Center, Cleveland, OH.

Co-I

USA

National Heart, Lung, and Blood Institute (NHLBI)

May 2011

Hemodialysis Access Duplex Ultrasound Surveillance and Cost Considerations. University Hospitals Case Medical Center, Cleveland, OH.

P.I.

USA

N/A

Investigator initiated

N/A

Investigator initiated

Mar 2011 – Oct 2014

LEVANT-2. Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the MoxyTM Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries. University Hospitals Case Medical Center,

Co-I

USA

N/A

C.R.Bard

Jan 2011 – Dec 2012

ENGAGE-PAS. Post-approval study evaluating the long term safety and effectiveness of the Endurant Stent Graft System. University Hospitals Case Medical Center, Cleveland, OH.

Co-I

USA

N/A

Medtronic Endovascular

Jan 2011 – Dec 2011

CVRxÒRheos Carotid BaroreceptorStimulator Pivotal Trial. University Hospitals Case Medical Center, Cleveland, OH.

P.I.

USA

N/A

CVRx Inc.

Aug 2011 – Dec 2016

CVRxÒRheos Carotid Baroreceptor Stimulator Pivotal Trial. Temple University Hospital, Philadelphia, PA

Sub-I

USA

N/A

CVRx Inc.

Jan 2008 – Mar2009

SmartGraftTM – Wireless Flow & Volume Sensing PTFE Bypass graft, and H-DGT – Flow sensing catheter. Temple University Hospital, Philadelphia, PA

Sub-I

USA

National Heart, Lung, and Blood Institute SBIR 1 R43 HL07139-01A1  P41-EB2182 

NHLBI

Oct 2007 – Dec 2013