Research Trials

Leading the Way in Clinical Research

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 trails, including those listed below. 

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

CIS Houma

  • The LUCY Study (active/enrolling)
    • 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

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).

None at this time

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).

CIS Lafayette at Lafayette General Medical Center

  • CloSys (active/enrolling)
    • To evaluate the safety and efficacy of the CloSys™ Closure System as an adjunct to standard compression in achieving hemostasis at the femoral arteriotomy access site.
    • The CloSys™ Closure System is intended to be used for the rapid preparation of a small sample of deheparinized autologous blood at the patient point of care for application to the tissue tract above an arteriotomy site to promote hemostasis.

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.

CIS Lafayette at Lafayette General Southwest

  • ERIC (active/enrolling)
    • This is a proof of concept trial using ranolazine in patients with known CAD and reduced left ventricular function, EF < 40%. We propose that ranolazine therapy will result in demonstrative improvements in cardiac function that can be objectively assessed using the parameters measured with CPET. We propose that demonstrative improvement in CPET parameters on ranolazine will translate into improved patient outcomes for this patient population.

CIS Opelousas

  • 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.CIS at Lafayette General Medical Center
    • 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).

CIS Houma

  • Parachute IV (active/enrolling)
    • The primary objective of Phase I is to demonstrate the reasonable assurance of safety of the CKI Parachute implant in the patients with NYHA Class III or IV (AMBULATORY) heart failure due to ischemic heart disease at 30 days. The primary objective of the combined Phase I&II is to evaluate the reasonable assurance of safety and effectiveness of the CKI Parachute implant in the treatment of patients with NYHA Class III or IV (AMBULATORY) heart failure due to ischemic heart disease. 
  • Reduce LAP(active/enrolling) 
    • 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.

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] 

CIS Houma

  • RANEXA (active/enrolling)
    • To determine if subjects suffering from diabetic peripheral neuropathic pain treated with ranolazine will have a greater reduction in pain compared to placebo.
  • COPPER A (active/enrolling)

    • The purpose of the COPPER-A study is to demonstrate the safety and efficacy of paclitaxel administration using the OPC for the prevention of restenosis in infrainguinal de novo and restenotic femoropopliteal lesions. Subjects will be treated with the endovascular intervention selected by the treating physician in reference vessels ranging from 4mm to 7mm in diameter. Following the achievement of optimal interventional results (less than thirty (30) percent residual stenosis without stenting) the OPC will be placed at the interventional treatment area and paclitaxel will be delivered to the treated segment. Data will be collected to assess acute safety, long-term safety and durability to demonstrate the safety and efficacy of paclitaxel delivered with the ACT, Inc. OPC device. 
       
  • COPPER B (active/enrolling)
    • The purpose of the COPPER B study is to assess the feasibility, safety, and initial efficacy of paclitaxel administration using the OPC for the prevention of restenosis in infrapopliteal de novo and restenotic lesions and occlusions using a novel catheter, the OPC.
  • 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.


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.

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 (active/enrolling)
    • 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. 
  • SALUS (active/enrolling)
    • The Direct Flow Medical Transcatheter Aortic Valve System is indicated for symptomatic patients with severe aortic valve stenosis who require replacement of their native aortic valve, who have a predictive operative mortality or serious irreversible morbidity risk of greater than or equal to 50% at 30 days with surgical aortic valve replacement or are deemed not suitable for surgery for other reasons following evaluation by a cardiac surgeon.
  • TRANSCAVAL (active/enrolling)
    • 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.