Bleeding



Bleeding

Title:

Purpose: To evaluate the safety and efficacy of Beriplex® P/N so that it can be licensed and sold in the United States. The study is

designed to show that Beriplex® P/N is at least as effective as (or no worse than) human plasma in returning thinned blood

towards normal.

Eligibility Male and female patients in the ICU at Sinai Hospital of Baltimore, 18 years of age or older who have received oral vitamin

K-antagonist therapy and have acute major bleeding.

Principal Investigator: Rubenfeld, Joshua

Phase: III

For more information, contact: Highfield, David

Telephone Number:

Email dhighfield@

Approved Enrollment Number: 6

Current Enrollment: 0

Cardiovascular Disease

Title:

Purpose: To determine the safety and efficacy of the Absolute Pro Peripheral Self-Expanding Stent System (Absolute Pro stent) and

the Omnilink Elite Peripheral Balloon-Expandable Stent System (Omnilink Elilte stent) in subjects with atherosclerotic de

novo or restenotic lesions in the native common iliac artery and/or native external iliac artery.

Eligibility Subject must be at least 18 and less than 90 years of age, and have had a history of symptomatic claudication (Rutherford

Becker Clinical Category 2-3) or ischemic rest pain (Rutherford Becker Clinical Category 4).

Principal Investigator: Prewitt, Kerry C.

Phase: III

For more information, contact: Dudek, Audrey

Telephone Number: 410-583-1170

Email adudek@

Approved Enrollment Number: 10

Current Enrollment: 0

Cardiovascular Disease

Title:

Purpose: To identify the optimal duration of dual antiplatelet therapy in subjects who undergo stenting procedures.

Eligibility Study subjects with ischemic heart disease due to stenotic lesions in either native coronary arteries or coronary artery bypass

grafts undergoing PCI with stent placement and no contraindications to prolonged DAPT are eligible to be enrolled in this

study. Subjects may have multi-vessel treatment.

Principal Investigator: Gurbel, Paul A.

Phase: IV

For more information, contact: Bliden, Kevin

Telephone Number: 410-601-4795

Email kbliden@

Approved Enrollment Number: 50

Current Enrollment: 0

Cardiovascular Disease

Title:

Purpose: To provide evidence that point-of-care genetic and platelet function testing can be successfully used to identify patients at

ischemic risk and alter therapy using an algorithm to guide clinicians in the management of antiplatelet therapy.

Eligibility Subjects, 18 years of age or older, who have ischemic heart disease due to stenotic lesions in either native coronary arteries or

coronary artery bypass and undergo PCI with stent placement and have no contraindication to prolonged dual antiplatelet

therapy (=1 year) are eligible to be in the study.

Principal Investigator: Gurbel, Paul A.

Phase: III

For more information, contact: Bliden, Kevin

Telephone Number: 410-601-4795

Email kbliden@

Approved Enrollment Number: 1500

Current Enrollment: 0

Carotid Artery Disease

Title:

Purpose: To collect data about patients' medical experiences and conditions following treatment of carotid stenosis using one of Abbot

Vascular's carotid stent systems and embolic protection systems.

Eligibility Anyone that has a blockage of the carotid artery and is considered at high risk for carotid endarterectomy surgery.

Principal Investigator: Mastali, Kourosh

Phase: IV

For more information, contact: Dudek, Audrey

Telephone Number: 410-583-1170

Email adudek@

Approved Enrollment Number: 50

Current Enrollment: 0

Coronary Heart Disease

Title:

Purpose: To evaluate the safety and efficacy of the REG1 Anticoagulation System in ACS patients undergoing cardiac catheterization

by determination of the clinically acceptable dose range of RB007, which can be used to reverse the anticoagulant effect of

RB006.

Eligibility Male or female subject, 18 - 85 years of age (inclusive) who are admitted for Acute Coronary Syndrome at Sinai Hospital's

Heart Center to undergo cardiac catheterization.

Principal Investigator: Gurbel, Paul A.

Phase: II

For more information, contact: Bliden, Kevin

Telephone Number: 410-601-4795

Email kbliden@

Approved Enrollment Number: 25

Current Enrollment: 0

Coronary Heart Disease

Title:

Purpose: To evaluate the effect of dalcetrapib treatment for 2 years on atherosclerotic disease progression - as assessed by coronary

intravascular ultrasound (IVUS) and carotid B-mode ultrasound - in patients with coronary artery disease (CAD).

Eligibility Male and female patients over 18 years of age scheduled for clinically indicated coronary angiography and possible ad hoc

percutaneous coronary intervention (PCI). Evidence-based management of LDL-C cholesterol, at a minimum to include

medical and dietary treatment to a target level of ................
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