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 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.

Abdominal Aortic Aneurysm

CIS Houma

  • The LUCY Study (followup)
    • A prospective, consecutively enrolling, non-randomized multi center post-market registry to evaluate the low profile (14F) Ovation Prime® Abdominal Stent Graft System with the Ovation iX™ Iliac Stent Graft when used in the endovascular treatment of female patients
    • The primary objectives of the LUCY Study are to demonstrate the clinical benefits associated with endovascular repair using the low profile (14F) Ovation Prime Abdominal Stent Graft System with the Ovation iX Iliac Stent Graft in female patients, specifically to include:
      • High eligibility rates in female patients, including those with small access vessel diameter, short neck length, and higher neck angulation
      • ​Low access-related vascular complications 
      • ​​Low mortality

Cardiovascular Disease Trials

CIS at Lafayette General Medical Center

  • ODYSSEY (active/enrolling)
    • The primary objective of this study is to compare the effect of SAR236553 with placebo on the occurrence of cardiovascular events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) in patients who have experienced an acute coronary syndrome (ACS) event 4 to 16 weeks prior to randomization and are treated with intensive statin therapy (defined as atorvastatin 40 or 80 mg, or rosuvastatin 20 or 40 mg) or at maximally tolerated dose of these given statins, or other non statin LMT(s).

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.

CIS Opelousas

  • REVEAL- TIMI-55 (active/enrolling)
    • The Randomized Evaluation of the Effects of Anacetrapib Through Lipid-modification (REVEAL) trial aims to determine whether lipid modification with anacetrapib 100mg daily reduces the risk of coronary death, myocardial infarction (MI) or coronary revascularization (collectively known as major coronary events) in patients with circulatory problems who have their Low-density Lipoprotein (LDL) cholesterol level treated with a statin.

CIS at Lafayette General Medical Center

  • ODYSSEY (active/enrolling)
    • The primary objective of this study is to compare the effect of SAR236553 with placebo on the occurrence of cardiovascular events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) in patients who have experienced an acute coronary syndrome (ACS) event 4 to 16 weeks prior to randomization and are treated with intensive statin therapy (defined as atorvastatin 40 or 80 mg, or rosuvastatin 20 or 40 mg) or at maximally tolerated dose of these given statins, or other non statin LMT(s).

Closure or Catheter Device Trials

CIS Lafayette at Lafayette General Medical Center

    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 Opelousas

  • ODYSSEY (followup)
    • The primary objective of this study is to compare the effect of SAR236553 with placebo on the occurrence of cardiovascular events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) in patients who have experienced an acute coronary syndrome (ACS) event 4 to 16 weeks prior to randomization and are treated with intensive statin therapy (defined as atorvastatin 40 or 80 mg, or rosuvastatin 20 or 40 mg) or at maximally tolerated dose of these given statins, or other non statin LMT(s).

Heart Failure Trials

CIS Houma

  • 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).

  • Counter HF (followup) 
    • The purpose of the study is to determine whether the use of the C-Pulse as a treatment for patients in moderate to severe heart failure (HF) has demonstrated safety and efficacy, such that the C-Pulse System merits Food and Drug Administration (FDA) approval to market the device in the United States.

CIS at Lafayette General Medical Center

  • Cardio Mems HF (active/enrolling) 
    • 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.

Hypertension Trials

Houma

  • REDUCE-HTN: REINFORCE (active/enrolling)
    • To assess safety and efficacy of the Vessix™ Renal Denervation System for the treatment of uncontrolled hypertension [off-treatment office systolic blood pressure (OSBP) ≥150 mmHg and ≤180 mmHg] 
  • Rox (active/enrolling)
    • To evaluate the safety and effectiveness of the ROX Coupler used to create an arteriovenous anastomosis in the iliac region (between the iliac artery and vein) in subjects with hypertension.

Peripheral Arterial Disease Trials

CIS Houma

  • COPPER A (active/enrolling)
    • 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 (active/enrolling)

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

  • LUTONIX (active/enrolling)
    • To assess the safety and efficacy of the Lutonix DCB for treatment of stenosis or occlusion of native below-the-knee arteries.
  • MIMICS 2 (active/enrolling)

    • 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.

  • Antegrade (active/enrolling)
    • The objective of the ANTEGRADE-PVD registry is to collect procedural outcomes data when the Cardiva VASCADETM Vascular Closure System (VCS) is used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.

  • Ranger II (active/enrolling)
    • 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).

  • STOP-PAD (active/enrolling)
    • To investigate the efficacy of the administration of JVS-100 delivered via direct intramuscular injections on a 3 month and 6 month composite endpoint of wound progression, healing and limb loss in patients with severe peripheral arterial disease with non-healing chronic wounds who undergo an open bypass grafting or endovascular procedure for treatment of popliteal/infrapopliteal disease and are dosed with 2 administrations of IP, the first within 12 days and the second 3 months following the procedure.

  • 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.

CIS at 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 (active/enrolling)

    • 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.

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.
       
  • EVALVE (followup)
    • Prospective, multi-center, randomized study of the Evalve Inc., Cardiovascular Valve Repair System, MitraClip™, in the treatment of mitral valve regurgitation. A second arm of the study is a registry of patients treated with MitraClip who have been determined to have a high risk of operative mortality.
       
  • 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. 
       
  • TRANSCAVAL (followup)
    • The objective of this protocol is to further study the feasibility of caval-aortic access to enable transcatheter aortic valve replacement in patients who are not good candidates for conventional access approaches.
       
  • 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 (active/enrolling)
    • 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.