Explore This Research Program

Overview

Coronary Artery Disease (CAD) results from cholesterol deposits, blood clots and inflammation within the coronary arteries. Plaque build-up can block the arteries and decrease the flow of nutrient-rich blood to the heart muscle. Over time, this decreased blood flow can cause chest pain (“angina”), difficulty breathing, and other symptoms. Heart disease, the leading cause of death in the United States, is most frequently caused by such blockages or narrowings within the heart arteries. Percutaneous coronary interventions, known as angioplasty or coronary stent procedures, are used to open blocked heart arteries to improve blood flow to the heart muscle. Our research seeks to improve clinical outcomes in patients with coronary artery disease undergoing percutaneous coronary interventions.

The innovative research being performed at Massachusetts General Hospital has contributed to the development of novel coronary stents and other devices used to open blocked heart arteries. In addition, our clinical and translational research program investigates and develops novel devices that allow us to see inside the heart arteries to better understand the morphology of heart artery blockages and also to deepen our understanding of the biology responsible for their formation.

Coronary Artery Disease Clinical Trials

Clinical Research Trials

BIO-FLOW VII

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

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

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 InvestigatorFarouc 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 Pivotal Trial

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

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: 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
OPTIMIZE

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
IMPROVE

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
SPIRIT 48

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: Study start-up
  • Source: Industry-initiated
SynIVUS-DAPT

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
Teleflex CTO-PCI

Teleflex CTO-PCI: Chronic Total Occlusion Percutaneous Coronary Intervention CTO-PCI Study

Summary: Teleflex has developed a series of guidewires and catheters that are being studied under this protocol for the intended use of facilitating the safe and effective crossing of conventional guidewires beyond the lesion via either a true lumen or subintimal pathway. The Teleflex study devices include several catheters and guidewires. All study devices are currently 510(k) cleared for non-CTO indications. The data captured in this study will be used to support U.S. Food and Drug Administration (FDA) 510(k) clearance for CTO indications.

  • Primary Investigator: Farouc Jaffer, MD, PhD
  • Study Population or Disease Focus: The population for this study is subjects with signs and/or symptoms considered typical of ischemic heart disease attributed to a de novo CTO in a native coronary artery who are suitable candidates for a percutaneous revascularization
  • Status: Enrolling
  • Source: Industry-initiated
XIENCE 28

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

Registries and Other Research

OPTIMUM

OPTIMUM: Outcomes of Percutaneous revascularization for Management of surgically ineligible Patients with Multivessel or left main coronary artery disease: A Prospective Registry

Summary: The OPTIMUM registry is a minimal risk observational study that uses a prospective cohort design to follow patients who have multivessel or left main coronary artery disease and are deemed ineligible for coronary artery bypass surgery. 75% of patients enrolled will undergo PCI and the other 25% will be medically managed. There are 8 study objectives, but the main objective is to compare the health status and clinical outcomes of surgically ineligible multivessel or left main CAD patients treated with PCI compared to those treated with medical therapy alone.

  • Primary Investigator: Farouc Jaffer, MD, PhD
  • Study Population or Disease Focus: Patients with severe multivessel and/or left main CAD deemed surgically ineligible by the Heart Team after consultation by a cardiac surgeon
  • Status: Closed to enrollment; follow-up only
  • Source: Industry-initiated
PK Papyrus Covered Coronary Stent

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

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

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