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Displaying 1 - 15 of 15

Guided Physiologic Stenting

Condition: Heart Disease / Coronary Artery Disease
Investigator: Megha Prasad
Status: Currently Recruiting
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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Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature (ELEGANCE)

Condition: Heart Disease / Peripheral Arterial Disease
Investigator: Sahil Parikh, MD
Status: Currently Recruiting
This study aims to collect information about the symptoms and treatments of patients who have severely clogged arteries and are treated with commercially available Boston Scientific Corporation drug-eluting devices marketed for the treatment of lesions located in the peripheral vasculature. Participation in the study is expected to last for up to two (2)…
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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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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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Observational Study to Assess Transradial Access for Treatment in the Lower Extremities (R2P Registry)

Condition: Heart Disease / Peripheral Arterial Disease
Investigator: Sanjum Sethi, MD, MPH
Status: Closed
This is a prospective, multi-center, observational, post-market study that will evaluate the safety and procedural success of performing trans-radial access for treatment of atherosclerotic lesions in the lower extremities. This research study will collect outcome data of patients undergoing percutaneous endovascular treatment of Peripheral Artery Disease (…
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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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Comparison of a device that delivers sonic energy (sound) versus standard balloon to disrupt hard, calcified vascular blockages

Condition: Heart Disease / Peripheral Arterial Disease
Investigator: Sahil Parikh, MD
Status: Closed
This study is for patients who suffer from a condition where one of the blood vessels that deliver blood to your leg has a significant narrowing. This is called peripheral artery disease (PAD). The narrowing may be suitable for a treatment technique called balloon angioplasty. One of the therapies that has been used to treat PAD is balloon angioplasty. It…
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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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SCOPE CLI: Shifting Care and Outcomes for Patients With Endangered Limbs - Critical Limb Ischemia

Condition: Heart Disease / Peripheral Arterial Disease
Investigator: Sahil Parikh, MD
Status: Closed
This study is to collect information about the symptoms and treatments of patient who have severely clogged arteries and to learn about their outcomes at one year. If you choose to be part of this research, we will ask you to be involved in five interviews with study staff. Each interview will take about 30 minutes of your time and we will contact you…
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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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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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TAP-DANCE: Temsirolimus Alone or Paired with Dexamethasone After Femoropopliteal Revascularization (Femoral Artery Disease Procedure)

Condition: Heart Disease / Peripheral Arterial Disease
Investigator: Sahil Parikh, MD
Status: Closed
This study is to test if a combination drug/device therapy using TEMSIROLIMUS (Temsirolimus Injection), with or without the generic steroid DEXAMETHASONE (Dexamethasone Sodium Phosphate Injection), can be delivered safely into the tissue around the blood vessel wall at the time of an angioplasty ( which is a a procedure to open blocked arteries and restore…
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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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A study of the safety and effectiveness of a new drug coated balloon in blockages above the knee.

Condition: Heart Disease / Peripheral Arterial Disease
Investigator: Sahil Parikh, MD
Status: Closed
The purpose of this study is to deterimine if the Drug-Coated Chocolate Touch Balloon Catheters is safe and effective compared to a drug-coated balloon that is already approved in patients with a blockage in the blood vessels of their leg.
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