Vascular Surgery - Research

Numerous research projects are underway, including:

St. Boniface General Hospital

1. CREST Study "Carotid Revascularization Endarterectomy - Stenting Trial"

This is a multicentre trial to compare treatment with carotid stent versus carotid endarterectomy.

Principal Investigator: Randy Guzman
Co Investigator: Joshua Koulack, Brian Hardy, Stefan Pacin
Research Coordinator: Wendy Weighell
Sponsor: NIH

2. MASCOT Study "Double-blind, double-dummy, randomized, parallel group trial of SL650472 (three dose regimens versus placebo and Cilostazol), for 24-week improvement of walking distance in patients with stage II peripheral arterial disease who benefit from optimal prevention strategy including Clopidogrel (Protocol No: ACT4791)

This is a Phase 2 study involving approximately 580 patients from 85 centers in 9 countries to assess to safety and efficacy of SL650472 for intermittent claudication.

Sponsor: Sanofi-Aventis Canada Inc.
St. Boniface General Hopsital
Principal Investigator: Randy Guzman
Co Investigator: Robert Lotocki
Research Coordinator: Wendy Weighell
Heath Sciences Centre
Principal Investigator: Joshua Koulack
Co Investigator: April Boyd
Research Coordinator:  Lily Thomson

3. Cook Zilver Stent Study "Evaluation of the Safety and Performance of the Zilver® PTX™ Drug-Eluting Vascular Stent for Treating De Novo or Restenotic Lesions of the Above-the-Knee Femoropopliteal Artery" (Protocol #05-518)

This study assesses the ability of a drug-eluting vascular stent to maintain an open above-the-knee femoropopliteal (leg) artery, as well as to determine any rare adverse events.

Principal Investigator: Randy Guzman
Co Investigator: Barry Rusnak
Research Coordinator: Wendy Weighell
Sponsor: Cook Canada

4. Carotid Tissue Sample Study "Correlation Between Lipid Content And Atherosclerotic Pathology Human Carotid Tissues"

The purpose of the study is to determine the correlation between the % fat content in blood vessels and the extent of disease.

Principal Investigator: Paul Cheung
Co Investigator: Randy Guzman, Grant Pierce
Research Coordinator: Wendy Weighell

5. Legume Study "Exploring the Health Benefits Associated with Daily Pulse Consumption in Individuals with Peripheral Arterial Disease"

This study evaluates the health benefits that pulses (beans, lentils, chickpeas and dried peas) may have on cardiovascular health and particularly on peripheral rterial disease. The study will involve 25 to 30 patients from the Vascular Surgery Clinic at St. Boniface General Hospital who will eat pulses for 8 weeks.

Principal Investigator: Peter Zahradka
Co Investigator: Randy Guzman, Carla Taylor
Research Coordinator: Wendy Weighell
Sponsor: Pulse Canada and Manitoba Dept. of Science, Technology, Energy and Mines

6. Accela Study "A randomized, double-blind, placebo-controlled, parallel group trial of HMR1766 assessing the efficacy and safety of 3 doses of HMR1766 (25, 100, 200 mg OD) versus placebo with cilostazol, 100 mg BID as a calibrator, administered for 26 weeks in patients with Peripheral Arterial Disease (PAD) Fontaine stage II (Protocol HMR1766 - DFI6174 ACCELA)"

This is a Phase 2 study involving about 550 patients from about 100 hospitals or clinics worldwide to assess to safety and efficacy of HMR 1766 for claudication.

Sponsor: Sanofi-Aventis Canada Inc.
St. Boniface General Hopsital
Principal Investigator: Randy Guzman
Co Investigator: Joshua Koulack
Research Coordinator: Wendy Weighell
Health Sciences Centre
Principal Investigator: Asad Junaid
Co Investigator: Joshua Koulack, April Boyd
Research Coordinator: Lily Thomson

7. Flax Seed Study "The Effect Of Dietary Flaxseed On Improving Symptoms Of Cardiovascular Disease In Patients With Peripheral Arterial Disease"

This study is a two-year, double-blinded, placebo-controlled study designed to examine and compare the effects of ground flaxseed supplementation in volunteers with claudication secondary to lower extremity atherosclerotic arterial disease (peripheral arterial disease).

Principal Investigator: Randy Guzman
Co Investigator: Grant Pierce
Research Coordinator: Wendy Weighell
Sponsor: Flax Canada 2015 Inc

8. Microarray Analysis of Peripheral Arterial Disease (MiAnPAD)

The purpose of the study is to see if we can find patterns of gene expression in the white blood cells of patients with and without peripheral arterial disease and atherosclerosis.

Principal Investigator: Peter Zahradka
Co Investigator: Randy Guzman, Carla Taylor
Research Coordinator: Wendy Weighell
Sponsor: Med BioGene Inc. University of British Columbia

9. NAPA 3 Study "Phase 3, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Alfimeprase in Subjects with Acute Peripheral Arterial Occlusion (NAPA-3) (Protocol No. HA007)"

This is a phase 3 study, multicentre trial to assess the safety and efficacy of alfimeprase for acute peripheral arterial disease.

Sponsor: Nuvelo, Inc.
St. Boniface General Hospital
Principal Investigator: Randy Guzman
Co Investigator: Joshua Koulack
Research Coordinator: Wendy Weighell
Health Sciences Centre
Principal Investigator: Asad Junaid
Co Investigator: Joshua Koulack, April Boyd
Research Coordinator: Lily Thomson

Health Sciences Centre

1. Protocol number: ACT 4791
Double-blind, double-dummy, randomized, parallel group trial of SL650472 (three dose regimens versus placebo and cilostazol), for 24-week improvement of walking distance in patients with stage II peripheral arterial disease who benefit from optimal prevention strategy, including clopidogrel.

Granting Agency: Sanofi-Synthelabo May 2006

2. Protocol number: HA007
Phase 3, Multicenter, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Alfimeprase In Subjects With Acute Peripheral Arterial Occlusion (NAPA- 3)
Granting Agency: Nuvelo May 2006

3. Protocol: HA007 - Alfimeprase Study
Phase 3, Multicenter, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study to evaluate the efficacy and safety of Alfimeprase in Subjects with acute Peripheral Arterial Occlusion (NAPA-3)

Nuvelo
Principle Investigator: Dr. George Louridas 2006-March 2007
Principle Investigator: Dr. Joshua Koulack April 2007-

4. Protocol: ACT 4791 - MASCOT Study
Double-blind, double dummy, randomized, parallel group trial of SL650472 (three dose regimens versus placebo and cilosazol), for 24 week improvement of walking distance in patients with stage II peripheral arterial disease who benefit from optimal prevention strategy including clopidogrel.

Sanofi-Synthelabo
Principle Investigator: Dr. George Louridas to March 2007
Principle Investigator: Dr. Joshua Koulack as of April 2007

5. Protocol: DO-CIPO1-PvO
"A Multicenter Prospective, Randomized Comparison Study of Best-Dermon Versus Standard of Care in the Treatment of Diabetic Foot Ulcers"

Principle Investigator: Dr. John Embil to October 2006
Co-Investigator: Dr. Joshua Koulack

6. Protocol: VGF3554g
"A Phase II, Double-Blind, Randomized, Placebo-Controlled Study To Assess The Effect Of Topical Recombinant Human Vascular Endothelial Growth Factor (Telbermin) For Induction Of Healing Of Diabetic Foot Ulcers"

Principle Investigator: Dr. John Embil to November 2006
Co-Investigator: Dr. Joshua Koulack

7. Protocol: 3074K5-319WW
"A Multicenter, Randomized, Double-Blind, Comparison Study of the Safety and Efficacy of a Once-Daily Dose of Tigecycline Versus Ertapenem for the Treatment of Foot Infections in Subjects with Diabetes". Wyeth

Principle Investigator: Dr. John Embil January 2007 -
Co-Investigator: Dr. Joshua Koulack

8. Protocol number: HMR1766 - D16174 ACCELA
A randomized, double-blind, placebo-controlled, parallel group trial of HMR1766 assessing the efficacy and safety of 3 doses of HMR1766 (25, 100, 200 mg OD) versus placebo with cilostrazol, 100 mg BID as a calibrator, administered for 26 weeks in patients with Peripheral Arterial Disease (PAD) Fontaine stage II.

Granting Agency: Sanofi-Aventis Canada Inc.

Principle Investigator: Dr. Asad Junaid - May 2007 -
Co-Investigators: Dr. Joshua Koulack, Dr. April Boyd, Dr. Gregory Harding