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Displaying 1 - 18 of 18

The PROTECT IV Trial

Condition: Heart Disease / Coronary Artery Disease
Investigator: Michael Collins, MD
Status: Currently Recruiting
This is a Prospective, multicenter, randomized, parallel-controlled, open-label two-arm trial with an adaptive design that will randomize about 1252 subjects at approximately 120 US and international centers. The study is looking to see if a device called the Impella device will improve the way the heart works as well as if health is improved as compared to…
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AMGEN - Lipid Monitoring following Percutaneous Coronary Intervention (PCI)

Condition: Heart Disease / Coronary Artery Disease
Investigator: Ajay Kirtane, MD, SM
Status: Closed
This is a prospective, single-center, single-blind, two-arm, 1:1 randomized clinical trial. Patients who have undergone successful elective PCI will be screened with a lipid profile and eligible patients will be enrolled. Non-eligible patients will be enrolled in a registry. Randomization will be stratified by baseline LDL-C level and current statin therapy…
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Guided Physiologic Stenting

Condition: Heart Disease / Coronary Artery Disease
Investigator: Megha Prasad
Status: Closed
The primary objective is to demonstrate that physiologically-guided stenting using the Philips SyncVision iFR co-registration is superior with respect to clinical outcomes compared to PCI guided by angiography alone. Secondary objectives include: To evaluate the cost-effectiveness of physiology guidance with SyncVision compared to a standard of care PCI…
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DEEPER REVEAL - Bare Temporary Spur Stent System in Treating Patients with Critical Limb Ischemia (CLI)

Condition: Vascular Conditions
Investigator: Sahil Parikh, MD
Status: Closed
The objective of this study is to learn more about how safe and effective the Bare Temporary Spur Stent System is when used in patients who have blocked arteries in their lower limbs. The selection of subjects will be those with Critical Limb Ischemia (CLI), a form of Peripheral Arterial Disease (PAD) in which an artery (blood vessel) in the lower leg (…
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Study of Dynamic Coronary Roadmap Software During Percutaneous Coronary Intervention (DCR4Contrast Clinical Evidence Study)

Condition: Heart Disease / Coronary Artery Disease
Investigator: Ajay Kirtane, MD, SM
Status: Closed
This study is trying to determine if using a Dynamic Coronary Roadmap (which is a software used along with an x-ray imaging system) reduces the total iodine contrast volume per Percutaneous Coronary Intervention (PCI) procedure compared to procedures performed without Dynamic Coronary Roadmap. This X-ray system provides imaging support while directing the…
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Study of ESPRIT BTK System for Treatment of Critical Limb Ischemia

Condition: Vascular Conditions / Ischemia
Investigator: Sahil Parikh, MD
Status: Closed
The objective of the LIFE-BTK RCT is to evaluate the safety and efficacy of the ESPRIT BTK device (which is a bioresorbable polymeric scaffold with the everolimus drug and a bioresorbable polymeric coating mounted on a balloon dilatation catheter) compared to Percutaneous Transluminal Angioplasty (PTA), which is is a procedure that can open up a blocked…
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ClotTriever Outcomes (CLOUT) Registry

Condition: Vascular Conditions
Investigator: Edvard Skripochnik, MD, RPVI
Status: Closed
A research team at Columbia University Irving Medical Center is collecting information for a registry studying how safely and effectively the ClotTriever device works in treating patients at least 18 years old with Deep Vein Thrombosis (DVT), or blood clots in the vessels of the leg. The sponsor of this study, Inari Medical, Inc., is paying the research…
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A study for people with leg pain or/and non-healing wounds who have no surgical solution for their vascular problems

Condition: Vascular Conditions
Investigator: Roman Nowygrod, MD
Status: Closed
The purpose of this study is see if an experimental gene product, the Hepatocyte Growth Factor (HGF) Plasmid (AMG0001) which will be injected into the affected leg's muscles is effective in treating the blockages in your leg without causing adverse effects. Affected leg means the leg that has the severest disease relating to the blockage or narrowing…
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Chronic Total Occlusion Percutaneous Coronary Intervention (CTO-PCI Study)

Condition: Heart Disease / Coronary Artery Disease
Investigator: Dimitrios Karmpaliotis, MD
Status: Closed
A study evaluating the placement of any guidewire beyond complex narrowed arteries that are relatively common in patients undergoing ballon angioplasty (a procedure where a balloon is used to stretch open narrowed arteries). At least one Teleflex guidewire and at least one Turnpike catheter is used. The guidewires and catheters that are being studied are…
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Study of the Efficacy and Durability of the PhotoFix Patch in Vascular Repair and Reconstruction

Condition: Vascular Conditions
Investigator: Nicholas Morrissey, MD
Status: Closed
All vascular repair and reconstruction surgery requires patching material. PhotoFix, made of cow heart membrane, is one of the FDA-approved patches on the market for use in vascular repair and reconstruction surgery. Other vascular patches on the market are also available and used by other surgeons for procedures like the one you need. This trial will study…
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SARANAS

Condition: Heart Disease / Coronary Artery Disease
Investigator: Tamim Nazif, MD
Status: Closed
The Saranas Early Bird Bleed The Saranas study uses a device is called the Early Bird Bleed Monitoring System (EBBMS) and it is intended to provide physicians with an early indication of a potential internal bleeding complication due to vessel injury that may occur during the procedure before any symptoms present.
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ILumien IV

Condition: Heart Disease / Coronary Artery Disease
Investigator: Ajay Kirtane, MD, SM
Status: Closed
This study has been designed to treat patient with coronary artery disease and demonstrate the superiority of the OCT device used to select and guide the stenting procedure when collecting images and flow measures inside the blocked artery.
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Cross-Seal Investigational Device Trial in Subjects Scheduled for an Interventional Vascular Procedure

Condition: Vascular Conditions
Investigator: Virendra Patel, MD
Status: Closed
Are you scheduled for an interventional vascular procedure, such as a Trans-catheter Aortic Valve Replacement (TAVR), Endovascular Aneurysm Repair (EVAR), Thoracic Endovascular Aortic Repair (TEVAR), or Balloon Aortic Valvuloplasty (BAV)? If yes, you may be eligible for this trial. This research trial studies the safety and efficacy of an Investigational…
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The REFLECT Trial

Condition: Heart Disease / Coronary Artery Disease
Investigator: Susheel Kodali, MD
Status: Closed
This is a research study designed to look at the safety and effectiveness of the TriGUARD 3 cerebral embolic protection device in patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of the study is to assess whether the TriGUARD 3 can prevent death, stroke, more subtle signs of brain injury, and/or silent brain injury as measured…
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A Study of the Efficacy of the RelayPro Thoracic Stent Graft System as a Treatment for Acute, Complicated Type B Aortic Dissection

Condition: Vascular Conditions
Investigator: Virendra Patel, MD
Status: Closed
Has your doctor determined that you have Type B Aortic Dissection and you would like to learn more about an alternative to open surgery? Type B Aortic Dissection patients are being invited to take part in a research study of an investigational device. Bolton Medical, Inc., the company sponsoring this clinical trial, is studying an investigational device…
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A study for subjects with Vasculitis using study drug CCX168 for treatment

Condition: Vascular Conditions / Vasculitis
Investigator: Andrew Bomback, MD
Status: Closed
The purpose of this study is to evaluate the safety and tolerability of study drug CCX168 when it is given to patients who are receiving the standard therapy for a certain type of vasculitis called ANCA-associated vasculitis (AAV). The study will also assess the effectiveness of the study drug, CCX168, in combination with the standard treatment of AAV. This…
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FUnctional diagnoSIs of corONary Stenosis (FUSION)

Condition: Heart Disease / Coronary Artery Disease
Investigator: Ajay Kirtane, MD, SM
Status: Closed
The purpose of this study is to collect data for evaluating VFR (Virtual Flow Reserve) in comparison with standard FFR (Fractional Flow Reserve) when patients undergo a percutaneous coronary intervention (PCI) to treat blockage or narrowing in the heart artery or arteries.
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The DETOUR II Study of the PQ Bypass System to Improve Blood Flow to the Legs

Condition: Vascular Conditions
Investigator: Nicholas Morrissey, MD
Status: Closed
Has your doctor determined that you have Peripheral Arterial Disease (PAD), and that an artery in your upper leg is blocked as a result? Is blood flow to your upper leg(s) blocked?This study will test the safety and effectiveness of the PQ Bypass System (two catheters called the DETOUR Crossing Device and the DETOUR Snare) in improving blood flow to your…
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