Leading the Way in Clinical Research 

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Since its inception in 1983, CIS has been at the forefront of interventional cardiovascular research, earning international acclaim through participation in a growing number of research trials. CIS physicians serve as clinical investigators in these trials to research many new and innovative medical devices for patients. Additionally, CIS physicians share their knowledge of new devices by lecturing around the world about the latest methods of treating both cardiac and peripheral arterial disease. 

Our devotion is to advance patient care through innovative technology. As a leader of research and development, we are proud to currently offer more than 30 available research trials, including those listed below. 

To learn more about our research trials, please contact our research department nearest you or call 1-800-445-9676.

Arrhythmias

CIS Houma

  • Amaze (Enrolling)
    • This study is a prospective, multicenter, randomized (2:1) controlled study to evaluate the safety and effectiveness of the LARIAT Suture Delivery System to percutaneously isolate and ligate the LAA from the LA as an adjunct to planned PVI catheter ablation in the treatment of subjects with symptomatic persistent or longstanding persistent AF.

  • ECG Belt (active/enrolling)
    • The purpose is to compare ECG Belt Research System managed cardiac resynchronization therapy (CRT) patients and a control CRT group with respect to left ventricular (LV) remodeling. The ECG Belt Research System will be used at implant and follow-up to help implanters choose a suitable LV pacing site within the recommended locations for LV lead implantation and optimize pacing vector/timing parameters in line with the EHRA/HRS 2012 expert consensus statement.

  • EV ICD (Active/Enrolling)
    • The Medtronic EV ICD System (defibrillator and lead) is indicated for the automated treatment of patients who have experienced, or are at significant risk of developing, lifethreatening ventricular tachyarrhythmias. The main purpose of the EV ICD Pivotal study is to demonstrate safety and efficacy of the EV ICD System.

Abdominal Aortic Aneurysm

CIS Houma

  • EVAS II (active/enrolling)
    • Confirmatory Study (active/enrolling) To study the safety and effectiveness of the Nellix System for Endovascular Abdominal Aortic Aneurysm (AAA) repair. Procedures will be performed per the instructions for use, and per institutional protocols and standard of care for endovascular aneurysm repair. As such, this study will evaluate the safety and effectiveness of the device system among a wide range of physicians and in consecutively enrolled subjects to assess outcomes generalizability.

Cholesterol Trials

    None at this time.

Closure or Catheter Device Trials

    None at this time.

Coronary Artery Disease Trials

CIS Houma

  • ECLIPSE (active/enrolling)
    • 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). This is a prospective, randomized one to one (1:1), multi-center trial designed to evaluate vessel preparation with Orbital Atherectomy (OA) compared to conventional balloon angioplasty technique prior to stent implantation for the treatment of severely calcified coronary artery lesions.

  • Aegis II (active/enrolling)
    • CSL112 is indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in acute coronary syndrome. (ACS) patients diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and exclusive of unstable angina, including those managed with percutaneous coronary intervention or medically managed.

  • CADFEM (active/enrolling)
    • This trial is a prospective, multicenter, non-randomized, non-blinded, study to collect and store resting phase signals and subject meta data that will be used to develop, optimize and test machine-learned algorithms in future studies conducted by Analytics 4 Life.

  • Prevelance (active/enrolling)
    • To improve knowledge about the epidemiology of Lp(a) in patients with established cardiovascular disease (CVD)

CIS Lafayette General

  • Aegis II (active/enrolling)
    • CSL112 is indicated to reduce the risk of cardiovascular (CV) death,myocardial infarction (MI), and stroke in acute coronary syndrome. (ACS) patients diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and exclusive of unstable angina, including those managed with percutaneous coronary intervention or medically managed.

  • CADFEM (active/enrolling)
    • This trial is a prospective, multicenter, non-randomized, non-blinded, study to collect and store resting phase signals and subject meta data that will be used to develop, optimize and test machine-learned algorithms in future studies conducted by Analytics 4 Life.

Heart Failure Trials

CIS Houma

  • Alive (active/enrolling)
    • The purpose of the study is to demonstrate the safety and effectiveness of the BioVentrix Revivent TC System for the treatment of LV antero-septal aneurysms/scars in patients with symptomatic heart failure.

  • Parallax (Follow-up)
    • The primary objective of this study is to demonstrate that LCZ696 is superior to individualized medical therapy for comorbidities in reducing NT-proBNP from baseline after 12 weeks of treatment in patients with HFpEF.

  • Beat HF (Follow-up)
    • The BAROSTIM NEO - Baroreflex Activation Therapy for Heart Failure is a prospective, randomized trial in subjects with reduced ejection fraction heart failure. Subjects will be randomized in a 1:1 ratio to receive Barostim Activation Therapy with an implanted BAROSTIM NEO System in addition to medical management or to receive medical management alone (no device implant).

  • Heart-Fid (active/enrolling)
    • A double-blind, multicenter, prospective, randomized, placebo-controlled study designed to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo, in the treatment of participants in heart failure with a reduced ejection fraction and iron deficiency.

  • Reduce LAP HF I (followup)
    • The primary objective of this randomized controlled clinical study is to evaluate the peri-procedural safety and potential effectiveness (mechanistic effect) of implanting the IASD System II in heart failure patients with an LV ejection fraction >40%, elevated left sided filling pressures, and who remain symptomatic despite optimal Guideline Directed Medical Therapy (GDMT). Clinical outcomes will also be evaluated. A subset of the results of this study will be used to facilitate design of the U.S. pivotal trial.

  • Reduce LAP HF II (active/enrolling)
    • The primary objective of this randomized controlled clinical trial is to evaluate the clinical efficacy and safety of the IASD System II in symptomatic heart failure patients with an LV ejection fraction ≥40%, and elevated left sided filling pressures despite standard Guideline Directed Medical Therapy (GDMT).

  • Guide HF ( Active/Enrolling)
    • The CardioMEMS™ HF System will be used in this clinical trial to assess the effectiveness of PA pressure-guided HF management in a patient population that is not currently indicated, but are at risk for future HF events (HFHs or emergency department/hospital outpatient observation visits for intravenous diuretic therapy) or mortality. 3.1.4 Device Handling

  • CorCinch HFrEF (Active/Enrolling)
    • The objective of this trial is to evaluate the safety and performance of the AccuCinch system in patients with HFrEF.

  • Deliver (Enrolling)
    • The primary objective is to determine whether dapagliflozin is superior to placebo, when added to standard of care, in reducing the composite of CV death and HF events (hospitalisation for HF or urgent HF visit) in patients with HF and preserved systolic function.

CIS Lafayette General Medical Center

  • Cardio Mems HF (followup) 
    • The purpose of this Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with Class III Heart Failure in a commercial setting. The objective of this PAS is to confirm safety and effectiveness in a commercial setting.

  • Smart Registry (active/enrolling) 
    • To learn in a general Cardiac Resynchronization Therapy Defibrillators (CRT-D) population, which optimization techniques are used and how effective they are. It will compare 12-month response rates among different optimization methods and characterize which selected subject subgroups achieve better response than others.

CIS Opelousas

  • Cardio Mems HF (followup) 
    • The purpose of this Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with Class III Heart Failure in a commercial setting. The objective of this PAS is to confirm safety and effectiveness in a commercial setting.

Hypertension Trials

CIS Houma

  • Target BP I (active/enrolling)
    • To obtain an assessment of the efficacy and safety of renal denervation by alcohol-mediated neurolysis using the Peregrine System Kit (also referred to as Peregrine Kit) in uncontrolled hypertensive subjects when used in combination with antihypertensive medications.

Peripheral Arterial Disease Trials

CIS Houma

  • LUTONIX (followup)
    • To assess the safety and efficacy of the Lutonix DCB for treatment of stenosis or occlusion of native below-the-knee arteries.

  • MIMICS 2 (followup)
    • The BioMimics 3D stent is intended to improve luminal diameter in the treatment of symptomatic de-novo, obstructive or occlusive lesions in native femoropopliteal arteries with reference vessel diameters ranging from 4.0 – 6.0 mm.

  • Ranger II (followup)
    • To evaluate the safety and effectiveness of the Ranger™ Paclitaxel Coated Balloon for treating lesions located in the superficial femoral and proximal popliteal arteries (SFA/PPA).

  • SAVAL (active/enrolling)
    • To demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs percutaneous transluminal angioplasty (PTA).

  • TOBA II (Follow-up)
    • To evaluate the safety and efficacy of the Tack Endovascular System in subjects with below the knee (BTK) peripheral artery disease (PAD) as compared to a predefined performance goal (PG) established from published, peer reviewed scientific literature related to below-the-knee (BTK) PAD.

  • The Chocolate Touch Study (active/enrolling)
    • To show sufficient safety and effectiveness of the Chocolate Touch® for use in superficial femoral or popliteal arteries with the intention of obtaining regulatory approval to market this device in the US.

  • Illuminate BTK (Enrolling)
    • The purpose of this study is to demonstrate the safety and effectiveness of the Stellarex™ 0.014” OTW drug-coated angioplasty balloon (Stellarex balloon) for treatment of lesions in the popliteal or infra-popliteal arteries compared to a plain old balloon angioplasty (POBA) catheter. In addition, reference data on Subjects enrolled in the Vessel Preparation Registry will be obtained for the treatment of non-crossable and/or failed pre-dilatation lesions in the popliteal or infrapopliteal arteries.

  • Fast II (Enrolling)
    • To evaluate the safety and effectiveness of the Cardio Flow FreedomFlow™ Orbital Circumferential Atherectomy System for atherosclerotic plaque removal and vessel compliance modification in de novo native target lesions in the peripheral vasculature of the lower extremities.

  • STAND (Pending)
    • To evaluate the safety and effectiveness of using the MicroStent® Peripheral Vascular Stent System, hereafter referred to as the MicroStent® System, for the treatment of infrapopliteal lesions in subjects with peripheral arterial disease.

CIS Lafayette General Medical Center

  • MIMICS 2 (followup) 
    • The BioMimics 3D stent is intended to improve luminal diameter in the treatment of symptomatic de-novo, obstructive or occlusive lesions in native femoropopliteal arteries with reference vessel diameters ranging from 4.0 – 6.0 mm.

CIS Lafayette General Southwest

  • UltraScore (Enrolling) 
    • This is a prospective, multi-center, single-arm, real-world study to assess the clinical use of the Bard® UltraScore™ Focused Force PTA balloon for the treatment of stenotic lesions of the superficial femoral artery (SFA), popliteal artery, and infra-popliteal arteries (posterior tibial, anterior tibial and peroneal arteries).

  • Reach PVI (follow-up) 
    • The purpose of this study is to prospectively evaluate acute clinical outcomes of orbital atherectomy (OA) via transradial access (TRA) for treatment of peripheral artery disease (PAD) in lower extremity lesions.

Valve Trials

CIS Houma

  • COREVALVE (followup)
    • Expanded Use - To evaluate the safety and efficacy of the Medtronic CoreValve® System for the treatment of symptomatic severe aortic stenosis in subjects with significant comorbidities in whom the risk of surgical aortic valve replacement has a predicted operative mortality or serious, irreversible morbidity risk of ≥50% at 30 days.

  • Pivotal (follow-up)
    • ER- To evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects necessitating aortic valve replacement, with predicted operative mortality or serious, irreversible morbidity risk of ≥ 50% at 30 days.

    • HR- To evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery.

  • CAS (follow-up)
    • To evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects necessitating aortic valve replacement, with predicted operative mortality or serious, irreversible morbidity risk of ≥15% and <50% (High Risk) or ≥ 50% (Extreme Risk) at 30 days.

  • SURTAVI (followup)
    • The purpose of this study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System.

  • CoreValve Low Risk (active/enrolling)
    • Demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is non-inferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR.

  • AltaValve (Active/Enrolling)
    • To assess safety and performance of the AltaValve for the treatment of severe MR in subjects who are considered high risk for mortality and morbidity from conventional open-heart surgery.

  • CorCinch PMVI (Active/Enrolling)
    • The objective of this trial is to evaluate the safety and performance of the AccuCinch System in patients with recurrent MR after PMVI.

Miscellaneous Trials

CIS Houma

  • Site Seal (Active/Enrolling)
    • The primary safety objective of this clinical trial is to demonstrate that the SiteSeal SV is a safe adjunctive compression device for hemostasis after small vessel endovascular procedures.

CIS Lafayette General Medical Center

  • Clout ( Active/Enrolling)
    • The primary objective of this study is to evaluate real world patient outcomes after treatment of acute and non‐acute lower extremity deep venous thrombosis (DVT) with the ClotTriever Thrombectomy System.

CIS Opelousas

  • Flash ( Active/Enrolling)
    • The primary study objective is to evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism (PE). The use of the device will be assessed in a real-world population, with eligibility criteria that closely approximate its use in clinical practice.

  • Clout( Active/Enrolling)
    • The primary objective of this study is to evaluate real world patient outcomes after treatment of acute and non‐acute lower extremity deep venous thrombosis (DVT) with the ClotTriever Thrombectomy System.