Interventional Coronary Artery Disease Research

AGENT IDE: A Prospective, Randomized, Multicenter Trial to Assess the Safety and Effectiveness of the AgentTM Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects with In-Stent Restenosis (ISR)

Summary: The purpose of this study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter compared to balloon angioplasty (POBA) in patients with in-stent restenosis (ISR) of a previously stented native coronary artery.

• Primary Investigator: Farouc Jaffer, MD
• Study Population or Disease Focus: Patients with In-Stent Restenosis who are eligible for a PCI (percutaneous coronary intervention)
• Status: Enrolling
• Source: Industry-initiated

BIO-FLOW VII: A prospective multicenter study to confirm the safety and effectiveness of the Orsiro SiroLimus Eluting Coronary Stent System in the treatment of subjects with up to three de novo or restenotic coronary artery lesions - VII

Summary: The purpose of this clinical research study is to collect information on how well the Orsiro stent, an FDA approve drug-eluting stent, works in a real-world setting. There are no investigational or experimental procedures that you will experience in this study.

• Primary Investigator: Darshan Doshi, MD
• Study Population or Disease Focus: Patients with CAD who are treated with the Orsiro stent
• Status: Closed to enrollment; follow-up only
• Source: Industry-initiated

DEFINE GPS: Distal Evaluation of Functional performance with Intravascular sensors to assess the Narrowing Effect: Guided Physiologic Stenting

Summary: Demonstrate that PCI guided by iFR Co-registration is associated with superior clinical outcomes compared to PCI guided by angiography alone

• Primary Investigator: Darshan Doshi, MD
• Study Population or Disease Focus: Patients having stable or unstable ischemic heart disease with an indication for a cardiac catheterization for diagnostic and/or treatment purposes
• Status: Study start-up
• Source: Industry-initiated

Disrupt CAD III Study: Prospective, Multicenter, Single-Arm, Global IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2 Coronary IVL Catheter in Calcified Coronary Arteries

Summary: The objective of this investigational device exemption (IDE) study is to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System to treat de novo, calcified, stenotic, coronary lesions prior to stenting.

• Primary Investigator: Farouc Jaffer, MD, PhD
• Study Population or Disease Focus: Subjects with de novo, calcified coronary artery lesions presenting with stable, unstable or silent ischemia that are suitable for percutaneous coronary intervention (PCI).
• Status: Closed to enrollment; follow-ups only
• Source: Industry-initiated

DTU-STEMI: Primary Unloading and Delayed Reperfusion in ST-Elevation Myocardial Infarction: The STEMI-DTU Trial

Summary: Demonstrate that primary left ventricular unloading and a thirty-minute delay-to-reperfusion of an Anterior STEMI, has the following effects: 1. reduction in infarct size; 2. reduction in the incidence of heart failure-related clinical events; 3. an acceptable safety profile.

• Primary Investigator: Igor Palacios, MD and Rahul Sakhuja, MD
• Study Population or Disease Focus: Adult presenting with anterior STEMIs
• Status: Enrolling
• Source: Industry-initiated

ECLIPSE: Evaluation of treatment strategies for severe calcific coronary arteries: Orbital atherectomy vs. conventional angioplasty technique prior to implantation of drug-eluting stents

Summary: The objective of this trial is to evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES).

• Primary Investigator: Rahul Sakhuja, MD
• Study Population or Disease Focus: Subjects with stable ischemic heart disease, acute coronary syndrome (NSTEMI or unstable angina) or stabilized recent STEMI undergoing percutaneous coronary intervention (PCI)
• Status: Enrolling
• Source: Industry-initiated

Guidance: Guidance During Chronic Total Occlusion (CTO) Interventions

Summary: This is a study to evaluate the utility of prototype software for chronic total occlusion (CTO) to provide segmentation, visualization of anatomical landmarks, and guidance within the coronary arteries during percutaneous coronary interventions (PCI).

• Primary Investigator: Farouc Jaffer, MD, PhD
• Study Population or Disease Focus: Patients undergoing CTO-PCI with a JCTO score >= 1 who have had pre-procedural CTA
• Status: Enrolling
• Source: PI-initiated

IMPROVE: IMPact on Revascularization Outcomes of intraVascular ultrasound guided treatment of complex lesions and Economic impact

Summary: To assess the impact of intravascular ultrasound (IVUS) on the treatment of complex lesions. To compare the outcomes of patients with complex lesions treated with imaging guidance with IVUS versus angiography only.

• Primary Investigator: Darshan Doshi, MD
• Study Population or Disease Focus: PCI with stent implantation involving a high risk or complex lesion
• Status: Study start-up
• Source: Industry-initiated

MINT Trial: Myocardial Ischemia and Transfusion

Summary: The purpose of this study is to compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic.

• Primary Investigator: Sammy Elmariah, MD
• Study Population or Disease Focus:  In hospital patients diagnosed with myocardial infarction who need a blood transfusion
• Status: Enrolling
• Source: NIH-funded

OPTIMIZE: The OPTIMIZE Trial to Assess the Procedural and Clinical Value of the Svelte IDS and RX Sirolimus-Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions in a Randomized Study

Summary: The OPTIMIZE Trial focusses on the use of coronary artery stents, designed to slowly release an immunosuppressive drug called Sirolimus, in patients experiencing atherosclerosis.

• Primary Investigator: Sammy Elmariah, MD
• Study Population or Disease Focus: Atherosclerosis
• Status: Follow-up only
• Source: Industry-initiated

PROTECT IV Trial: Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function

Summary: This study works to demonstrate that in high-risk patients with complex CAD and reduced left ventricular function undergoing PCI, PCI with Impella MCS is superior to PCI without Impella MCS in reducing the composite rate of all-cause death, stroke, durable LVAD implant or heart transplant, MI or hospitalization for cardiovascular causes at 3-year follow-up.

• Primary Investigator: Rahul Sakhuja, MD
• Study Population or Disease Focus: High-risk patients with complex CAD and reduced left ventricular function
• Status: Enrolling
• Source: Industry-initiated

REVEALPLAQUE: A Prospective Multicenter Study to Analyze Plaque using CCTA

Summary: This study will evaluate the level of agreement of quantification and characterization of coronary atherosclerosis between noninvasive CCTA-based (Coronary computed tomography angiography) and invasive IVUS (intravascular ultrasound).

• Primary Investigator: Farouc Jaffer, MD, PhD
• Study Population or Disease Focus: Stable patients with known CAD who have a CCTA showing stenosis and in whom clinically indicated IVUS is planned
• Status: Enrolling
• Source: Industry-initiated

RINGER EFIC: A Prospective, Multicenter, Single-arm Investigation of the Ringer Perfusion Balloon Catheter (Ringer IDE Clinical investigation)

Summary: The objective of this study is to demonstrate reasonable assurance that the Ringer catheter can be safely used to manage hemorrhage due to coronary vessel perforations while facilitating distal perfusion.

• Primary Investigator: Farouc Jaffer, MD, PhD
• Study Population or Disease Focus: Patients with coronary artery perfusion
• Status: Enrolling
• Source: Industry-initiated

ABT NG DES 48 Study: A Clinical Investigation to Assess the Abbott Next Generation Drug Eluting Stent 48mm Everolimus Eluting Coronary Stent System in Treatment of de novo Native Coronary Artery Disease

Summary: The objective of SPIRIT 48 is to evaluate the safety and effectiveness of the ABT NG DES 48 in improving coronary artery luminal diameter in subjects with coronary artery disease (CAD) due to de novo native coronary artery long lesions.

• Primary Investigator: Rahul Sakhuja, MD
• Study Population or Disease Focus: Subjects with a maximum of two de novo coronary artery lesions undergoing a percutaneous coronary artery revascularization procedure
• Status: Closed to enrollment
• Source: Industry-initiated

SynIVUS-DAPT: SYNERGY™ Stent System Implantation with Mandatory Intra-Vascular Ultra-Sound Guidance to Examine the Safety of Cessation of Dual Anti-Platelet Therapy in High Bleeding Risk Patients One Month (SYNIVUS-DAPT)

Summary: The purpose of this study is to examine whether discontinuation of Dual Anti-platelet Therapy (DAPT) at 1 month after IVUS-guided implantation of the SYNERGY™Stent is feasible. This is a prospective multicenter single-arm study designed to characterize the safety of 1 month of dual antiplatelet therapy (DAPT) in a patient population who are at increased risk for bleeding who are undergoing iLab IVUS-guided percutaneous coronary intervention (PCI) with a SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY™ Stent System). We hypothesize that the 1 to 13 month rates of Cardiac Death or Myocardial Infarction (SCAI definition), and Stent thrombosis after Boston Scientific IVUS-guided SYNERGY™ Stents implantation will be low and provide key hypothesis generating information to inform future larger-scale clinical studies.

• Primary Investigator: Farouc Jaffer, MD, PhD
• Study Population or Disease Focus: Patients undergoing PCI who are considered at high risk for bleeding
• Status: Enrolling
• Source: Industry-initiated

TARGET-IV NA: Firehawk Rapamycin Target Eluting Coronary Stent North American Trial

Summary: The aim of the TARGET-IV NA trial is to demonstrate the Firehawk® rapamycin eluting stent system in comparison to currently approved 2nd generation DES for the treatment of patients with ischemic heart disease with atherosclerotic target lesion(s) in the coronary arteries

• Primary Investigator: Dr. Rahul Sakhuja
• Study Population or Disease Focus: patients with ischemic heart disease (NSTEMI, recent STEMI, unstable angina and stable coronary disease), with atherosclerotic target lesion(s) in the coronary arteries
• Status: Enrolling
• Source: Industry-initiated

XIENCE 28: XIENCE 28 USA Study

Summary: The objective of this trial is to evaluate safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary intervention (PCI) with XIENCE stents.

• Primary Investigator: Rahul Sakhuja, MD
• Study Population or Disease Focus: HBR subjects from the general interventional cardiology population
• Status: Follow-up only
• Source: Industry-initiated

PK Papyrus Covered Coronary Stent

Summary: The intended purpose of the PK Papyrus stent graft is to repair the vessel without open-heart surgery and avoid the complications associated with surgery.

• Primary Investigator: Darshan Doshi, MD
• Study Population or Disease Focus: The PK Papyrus Covered Coronary Stent System (PK Papyrus) is designed for the treatment of acute perforations of native coronary arteries and coronary bypass for Compassionate Use or Emergency Use
• Source: Industry-initiated

PROGRESS-CTO: Prospective Global Registry for the Study of Chronic Total Occlusion Intervention

Summary: The goal of this multicenter, investigator-initiated registry is to collect information on treatment strategies and outcomes of consecutive patients undergoing CTO PCI among various participating centers. The information collected will be used to determine the frequency of CTO PCI performed at the participating sites and examine the procedural strategies utilized, and the procedural (both immediate and during follow-up) outcomes.

• Primary Investigator: Farouc Jaffer, MD, PhD
• Study Population or Disease Focus: Patients (over the age of 18) who have a chronic total occlusion and undergo PCI
• Status: Enrolling
• Source: PI-initiated

PROMS: Patient-reported Outcomes Registry for Coronary Revascularization

Summary: The Cardiac Catheterization Laboratory is currently engaged in a program to improve standardize the collection of symptom severity by integrating patient-reported outcomes into routine care. This information will be incorporated into the medical record, in order to allow providers to monitor symptom severity in a standardized fashion and to allow them to monitor their patients longitudinally. This system is being implemented solely to improve the quality of care provided to patients. This study is a registry which will retrospectively aggregate this data from the medical record for further research purposes, allowing for hypothesis and testing to further describe the relationship between care provided and patient symptom outcome.

• Primary Investigator: Farouc Jaffer, MD, PhD
• Study Population or Disease Focus: PAll patients undergoing chronic total occlusion percutaneous coronary intervention in the MGH cardiac cath lab
• Status: Enrolling
• Source: PI-initiated