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Current Grants and Clinical Research Trials

Clinical Research Trials

PEVAR: Prospective, Multicenter, Randomized Controlled Trial of Endovascular Aneurysm Repair Using a Bilateral Percutaneous Approach (PEVAR) vs. Standard Approach (SEVAR) Using the IntuiTrak Endovascular AAA Delivery System and the Prostar XL or Perclose ProGlide Suture-Mediated Closure
Jon Matsumura Principal Investigator
Status: Enrolling in September of 2010.

Detailed Description:
In >30 single center publications, percutaneous EVAR facilitated with the Prostar XL or ProGlide closure has been demonstrated to be feasible. To date, no multicenter, randomized controlled trials of the approach are available. Moreover, although the IntuiTrak System and the closure devices are commercially available in the US as FDA-approved devices, no EVAR device and no closure device is FDA approved for a totally percutaneous EVAR application.

The IntuiTrak System is indicated for the treatment of abdominal aortic aneurysms with aortic necks ranging in size from 18mm to 32mm. The System includes a 19Fr integrated introducer sheath, which is designed to reduce exchanges, and may be particularly important in a percutaneous approach. Moreover, the device is the only currently approved EVAR device with a contralateral percutaneous (9Fr) indication.

Patients with abdominal aortic aneurysm who are suitable candidates for endovascular repair using the IntuiTrak System and who meet the prospectively defined inclusion/exclusion criteria specific to the trial will be randomized to PEVAR or to standard EVAR using vascular exposure access in a ratio of 2:1. Physicians who are established experts in the field of percutaneous EVAR will participate in the trial.

CHOICE: Carotid Stenting For High Surgical-Risk Patients; Evaluating Outcomes Through The Collection Of Clinical Evidence
Principal Investigator(s): Girma Tefera, MD (Jon Matsumura Sub-Investigator
Status: Recruiting
[ClinicalTrials.gov: NCT00406055]

The CHOICE study will provide a mechanism for collection of data from Abbott Vascular’s Carotid Stent Systems and Embolic Protection Systems when used by a broad group of physicians under commercial use conditions. The original CAPTURE and EXACT studies had built-in features that limited the ability to collect on-going real world data because they restricted the number of sites that could participate (up to 150 sites) and limited enrollment at each site (up to 50 patients per site). This study will not have these restrictions. The CHOICE study will also provide an ongoing post-market surveillance mechanism for documentation of clinical outcomes and for possible extension of the Centers for Medicare and Medicaid Services (CMS) coverage to a broader group of patients

The Gore FREEDOM Study: GORE Flow Reversal System and GORE Embolic Filter Extension Study for the Ongoing Collection of Patient Outcomes
Principal Investigator(s): Girma Tefera, MD (Jon Matsumura Sub-Investigator)
Status: Recruiting (open to enrollment August 2011.
[ClinicalTrials.gov: NCT01343667]

Post marketing study with Gore Flow Reversal system
The objective of this study is to provide an ongoing evaluation of clinical outcomes
associated with the GORE Flow Reversal System and the GORE Embolic Filter when used for
embolic protection during carotid artery stenting.
Talecris Study: Jon Matsumura Sub-Investigator
A Phase 2, Randomized, Open-label (With Blinded Plasminogen Activator and Placebo Control Groups) Study to Evaluate the Effects of Different Intra-thrombus Infusion Regimens of Plasmin (Human) Compared to Plasminogen Activator and Placebo In Patients With Acute Lower Extremity Native Artery or Bypass Graft Occlusion
Principal Investigator(s): John R Hoch, MD
Status: Recruiting (Open to enrollment August 2011)
[ClinicalTrials.gov: NCT01222117]

More Information
The primary purpose of this Phase 2 study is to optimize Plasmin delivery by comparing 4
different delivery regimens in patients with acute peripheral arterial occlusion. The study
will also compare Plasmin to placebo and to plasminogen activators. The study will further
assess the safety and tolerability of Plasmin at the 150 mg dose.

CREATE PAS: Jon Matsumura Sub-Investigator
Carotid Revascul The purposes of this study are:
To provide additional safety and effectivenss infomration on teh commerical use of of Protégé® GPS™ and Protégé® RX Carotid Stent Systems and the SpiderFX® Embolic Protection Device. To evaluate rare and unanticipated adverse events. To evaluate the physician level of experience with carotid artery stenting procedures with adverse event rates.
Status: Awaiting IRB approval

AortaCore Imaging Lab Studies

:Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial (N-TA3CT)
Jon Mastumura Imaging Core Lab Director
Study Objective: The overall goal of the proposed study is to determine whether treatment with
doxycycline 100 mg p.o., b.i.d., in patients with small abdominal aortic aneurysms (3.5 to 5.0 cm
in diameter among men, 3.5 to 4.5 cm among women) is associated with reduced growth of the
aneurysm in diameter compared to growth with treatment with placebo over the course of two
years.

Core Lab Objective:
Imaging Core Laboratory staff will assess the abdominal aortic aneurysm measurements in duplicate (one reader, two readings) and create a database of each patient’s CT scan measurements. This database will include dates of CT scan receipt, initial review (if any) and definitive evaluation.
Upon receipt of a pre-randomization CT scan from a clinical site, the Imaging Core Laboratory will notify the clinical site (with copy to the Data Coordinating Center) whether the abdominal aortic aneurysm meets eligibility criteria for N-TA3CT (e.g., no renal artery or iliac artery involvement, maximum transverse diameter greater than 3.5 cm and less than 4.5 cm for women or 3.5 cm and 5.0 cm for men) within two working days of receipt.
At three-month intervals on days negotiated by the Data Coordinating Center and the Imaging Core Laboratory, the Imaging Core Laboratory will transfer CT scan data to the Data Coordinating Center at Perry Point, Maryland, for integration into the main study database, monitoring of CT

W.L. Gore TAG 08-01: Jon Matsumura Imaging Core Lab Director
Protocol # 08-01:Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection
Sponsor: W.L. Gore & Associates
Objective: The objective of this study is to determine the safety and efficacy of the GORE Conformable TAG Thoracic Endoprosthesis (CTAG) for treatment of subjects wth acute complicated type B aortic dissection.
Study population: Patients who have been diagnosed with acute complicated type B aortic dissection

Statistical Justification: This study uses a Bayesian adaptive design to compare to a performance goal specified in the protocol. Analysis will occur after 50 subjects complete 30 days of follow-up, and subsequently after the enrollment of each group of 25 subjects until the maximum sample size of 200 is reached. The study will stop enrollment when the performance goal is met with probablity levels as described in the protocol. Based on plans for site initiation and an assumption for accrual at each site of 2/3 patients per month, the duration of accrual could range from 18 months (for the minimum sample size of 50 subejcts) to 3 years (for the maximum sample size of 200 subjects) and the duration of follow up will be 5 years following the enrollment of the last subject. Estimated start date: December 2009. Estimated end date (accrual, minimum): August 2011. Estimated end date (accrual, maximum): December 2012. Estimated end date (follow-up, minimum): August 2016. Estimated end date (follow-up, maximum): December 2017.

W.L. Gore TAG 08-02: Jon Matsumura Imaging Core Lab Director
Protocol # 08-02: Title: Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Traumatic Transection of the Descending Thoracic Aorta
Objective: Determine safety and efficacy outcomes with the GORE
Conformable TAG® Thoracic Endoprosthesis for treatment of
traumatic transection of the descending thoracic aorta
Study population: Patients who have been diagnosed with traumatic transection of the descending thoracic aorta.

Statistical Justification: The sample size was computed to have a precision (half-width) for the confidence interval around the proportion of 30-day mortality <0.085. Based on plans for site initiation and an assumption for accrual at each site of 2/3 patients per month, the duration of accrual is anticipated to be 18 months. Estimated start date: November 2009. Estimated end date (accrual) July 2011. Estimated end date (follow-up) July 2016.

W.L. Gore TAG 08-03: Jon Matsumura Imaging Core Lab Director
Protocol # 08-03: Title: Evaluation of the GORE™ Conformable TAG® Thoracic Endoprosthesis for the Primary Treatment of Aneurysm of the Descending Thoracic Aorta
Objective: To evaluate the safety and efficacy of the GORE™ Conformable TAG® Thoracic Endoprosthesis for the Primary Treatment of Aneurysm of the Descending Thoracic Aorta
Study Population: Patients who have been diagnosed with aneurysm of the descending thoracic aorta.

Statistical Justification: The sample size was to rule out a rate of major device complications at one month of >17%. This was based on analysis of historical results from previous studies of the TAG device. Based on plans for site initiation and an assumption for accrual at each site of 2/3 patients per month, the duration of accrual is anticipated to be 18 months. Estimated start date: October 2009. Estimated end date (accrual) June 2011. Estimated end date (follow-up) June 2016.


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