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.

Atrial Fibrillation

CIS Houma

  • Previal/CAPS 2 (followup)
    • The WATCHMAN LAA Closure Technology is intended as an alternative to warfarin therapy for patients with non-valvular atrial fibrillation. The WATCHMAN LAA Closure Technology is designed to prevent embolization of thrombi that may form in the LAA, thereby preventing the occurrence of ischemic stroke and systemic thromboembolism.

  • 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.

Abdominal Aortic Aneurysm

    None at this time.

Carotid Vascular Disease Trials

None at this time.

Cholesterol Trials

CIS Houma

  • LOWER (active/enrolling)
    • This registry is designed to evaluate the long-term safety and effectiveness of lomitapide in clinical practice.

Closure or Catheter Device Trials

    None at this time.

Coronary Artery Disease Trials

CIS Houma

  • CANTOS (followup)
    • The purpose of this trial is to test the hypothesis that canakinumab treatment of patients with MI at least one month prior to study entry and elevated hsCRP will prevent recurrent cardiovascular events. A secondary hypothesis, that canakinumab treatment in patients with MI and pre-diabetes, will prevent new onset diabetes (NOD) will also be tested. The trial is pivotal for registration for canakinumab for cardiovascular risk reduction.
  • 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.

CIS Lafayette General

  • Aegis (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.

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 (active/enrolling) 
    • 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.

  • Victoria (active/enrolling) 
    • To evaluate the efficacy of the oral soluble guanylate cyclase (sGC) stimulator MK-1242 (vericiguat) in comparison to placebo on a background of standard of care in increasing the time to first occurrence of the composite of CV death or HF hospitalization in subjects with HFrEF.

  • Beat HF (active/enrolling) 
    • 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).

  • 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.

    • Victoria (active/enrolling) 
      • To evaluate the efficacy of the oral soluble guanylate cyclase (sGC) stimulator MK-1242 (vericiguat) in comparison to placebo on a background of standard of care in increasing the time to first occurrence of the composite of CV death or HF hospitalization in subjects with HFrEF.

    CIS Opelousas

    • Victoria (active/enrolling) 
      • To evaluate the efficacy of the oral soluble guanylate cyclase (sGC) stimulator MK-1242 (vericiguat) in comparison to placebo on a background of standard of care in increasing the time to first occurrence of the composite of CV death or HF hospitalization in subjects with HFrEF.

    • 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.

    • CIS Morgan City

    • 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 fo HF or urgent HF visit) in patients with HF and preserved systolic function.

Hypertension Trials

    None at this time.

Peripheral Arterial Disease Trials

CIS Houma

  • COPPER A (followup)
    • The purpose of this study is to assess the safety and efficacy of paclitaxel administration using the occlusion perfusion catheter (OPC) for the prevention of restenosis in infrainguinal de novo, restenotic femoropopliteal and infrapopliteal stenoses and occlusions, and in-stent restenosis.
       
  • GORE-ISR (followup)

    • The objective is to evaluate post-market safety and effectiveness of GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the SFA

  • 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).

  • Wing It (active/enrolling)
    • To evaluate the safety and effectiveness of the ReFlow Medical Wingman Catheter used to cross de novo or restenotic infrainguinal CTOs that cannot be crossed with a standard guidewire.

  • TOBA II (active/enrolling)
    • 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.

  • Turbo Power Laser Atherectomy and Drug Coated Balloon Angioplasty Data Collection (active/enrolling)
    • To determine outcomes of combined Turbo Power laser atherectomy + drug coated balloon (DCB) angioplasty for the treatment of femoropopliteal de novo/restenotic lesions and in-stent restenosis (ISR). Better understanding of these outcomes will help guide optimal treatment algorithms for this difficult to treat cohort of patients.

  • 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.

  • MicroStent® (Active/Enrolling)
    • To evaluate the safety and efficacy of the MMS MicroStent® Peripheral Stent System, hereafter referred to as the System.

  • 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.

  • CIS Lafayette General Medical Center

  • OPEN (followup) 
    • The primary objective of this clinical investigation is to evaluate the safety and efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System in patients with Superficial Femoropopliteal Arterial disease.

  • MIMICS 2 (followup) 
    • TThe 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).

Valve Trials

CIS Houma

  • COREVALVE (follow-up)
    • 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.

  • REFLECT (followup)
    • To assess the safety and efficacy of the TriGuard HDH embolic deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in comparison with an active control group of patients undergoing unprotected TAVI.