Cardiovascular Research Trials

CIS Houma

Performance II (Follow-Up)

• To evaluate the safety and effectiveness of the Neuroguard IEP System in subjects for the treatment of carotid artery stenosis at elevated risk for adverse events following carotid endarterectomy

CIS Houma

Horizon (Follow-Up)

• This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)

CIS Opelousas

Horizon (Follow-Up)

• This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)

Victorian II (Follow-up)

• The primary objective of this study is to demonstrate the superiority of inclisiran compared to placebo in reducing the risk of 3P-MACE (composite of CV death, non-fatal MI and non-fatal ischemic stroke) in participants with established ASCVD and a LDL-C >1.8 mmol/L (70 mg/dL)

CIS Lafayette General

Victorian II (Follow-up)

• The primary objective of this study is to demonstrate the superiority of inclisiran compared to placebo in reducing the risk of 3P-MACE (composite of CV death, non-fatal MI and non-fatal ischemic stroke) in participants with established ASCVD and a LDL-C >1.8 mmol/L (70 mg/dL)

CIS Gray

Victorian II (Follow-up)

• The primary objective of this study is to demonstrate the superiority of inclisiran compared to placebo in reducing the risk of 3P-MACE (composite of CV death, non-fatal MI and non-fatal ischemic stroke) in participants with established ASCVD and a LDL-C >1.8 mmol/L (70 mg/dL)

None at this time.

CIS Houma

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.

MedAlliance-ISR (Active/Enrolling)

• To demonstrate the safety and efficacy of the SELUTION SLR™ 014 DEB for treatment of bare-metal or drug-eluting in-stent restenosis (ISR).

CIS Lafayette General

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.

ECLIPSE (Follow-up)

• 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

Victorian – 1 Prevent  (Active/Enrolling)

• To demonstrate the superiority of inclisiran compared to placebo in reducing the risk of 4P-MACE (composite of CV death, non-fatal MI, non-fatal ischemic stroke, and urgent coronary revascularization)

CIS Baton Rouge

ECLIPSE (Follow-up)

• 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 Medical Center

CordiO HearO (Active/Enrolling)

• To determine the sensitivity and Unexplained Priority Notification Rate (UPNR) of Cordio Hear OTM in detecting impending episodes of heart failure decompensation requiring intervention.

CIS Houma

Reduce LAP HF II (Follow-up)

• 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).

CorCinch HFrEF (Active/Enrolling)

• The objective of this trial is to evaluate the safety and performance of the AccuCinch system in patients with HFrEF.

Rebalance (Active/Enrolling)

• The objective of this clinical evaluation is to assess the safety and initial effectiveness of catheter-based unilateral ablation of the right greater splanchnic nerve (GSN) in subjects having heart failure with preserved ejection fraction (HFpEF).

Victor (Follow-up)

• To evaluate the efficacy of vericiguat compared with placebo on reducing the risk of cardiovascular death or heart failure hospitalization. Also to evaluate the efficacy of vericiguat compared with placebo on reducing the risk of cardiovascular death.

CordiO HearO (Active/Enrolling)

• To determine the sensitivity and Unexplained Priority Notification Rate (UPNR) of Cordio Hear OTM in detecting impending episodes of heart failure decompensation requiring intervention.

Responder (Active/Enrolling)

• The primary objective of this clinical trial is to further evaluate the clinical efficacy of the Corvia Atrial Shunt in symptomatic heart failure patients with a left ventricular ejection fraction (LVEF) ≥ 40%, and elevated left sided filling pressures despite standard Guideline-Directed Medical Therapy (GDMT); and to confirm the treatment effect observed in the responder group of the REDUCE LAP-HF Randomized Trial II. (Corvia protocol 1601).

ALLAY-HF (Active/Enrolling)

• To evaluate the safety and efficacy of the Alleviant ALV1 System in patients with chronic heart failure (HF) and preserved ejection fraction (HFpEF) or mildly reduced ejection fraction (HFmrEF), who remain symptomatic despite appropriate guideline directed medical therapy (GDMT).

Prevail (Active/Enrolling)

• Characterize the impact of pulmonary artery denervation on the quality of life in Heart Failure Patients with Group 2 Pulmonary Hypertension

CIS Lafayette General

Victor (Follow-up)

• To evaluate the efficacy of vericiguat compared with placebo on reducing the risk of cardiovascular death or heart failure hospitalization. Also to evaluate the efficacy of vericiguat compared with placebo on reducing the risk of cardiovascular death.

CIS Opelousas

Victor (Follow-up)

• To evaluate the efficacy of vericiguat compared with placebo on reducing the risk of cardiovascular death or heart failure hospitalization. Also to evaluate the efficacy of vericiguat compared with placebo on reducing the risk of cardiovascular death.

None at this time.

CIS Lafayette General Medical Center

OSPREY (Active-Enrolling)

• The study objective is to confirm the safety and efficacy of the Misago® RX Self-expanding Peripheral Stent for use in the common and/or external iliac artery.

DEEPER Reveal (Active-Enrolling)

• To compare the safety and efficacy of the Bare Temporary Spur Stent System in subjects with infrapopliteal critical limb ischemia (CLI) to a pre-defined performance goal (PG) based on standard percutaneous transluminal balloon angioplasty (PTA).

CIS Houma

The Chocolate Touch Study (Follow-up)

• 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.

STAND (Follow-up)

• 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.

Life BTK (Follow-Up)

• To evaluate the safety and efficacy of the ESPRIT BTK, compared to PTA, in the planned treatment of diseased infrapopliteal lesions in patients with critical limb ischemia with up to two de novo or restenotic (prior PTA) lesions in separate vessels.

MIMICS-3d-USA Study (Follow-Up)

• This study evaluates safety, effectiveness, and device performance within a real-world clinical population of patients undergoing femoropopliteal intervention.

Elegance (Follow-up)

• Collection of Real-World Data (RWD), including populations previously not represented in Peripheral Vascular Disease (PVD) trials, health economics data, and to support the safe use of commercially available Boston Scientific Corporation (BSC) drug-eluting devices for the treatment of lesions located in the peripheral vasculature.

Dexterity AFP (Active/Enrolling)

• Limit the rate of clinically relevant loss of primary patency in the target fem-pop vein segment at 6 months following the procedure.

Dexterity SCI (Active/Enrolling)

• Limit the rate of clinically relevant loss of primary patency at 6 months following the procedure. Limit the incidence of composite major adverse events (MAE) at 30 days following treatment of an obstruction in the femoropopliteal segment.

MedAlliance BTK (Active/Enrolling)

• To demonstrate the superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in CLTI patients.

MedAlliance SFA (Active/Enrolling)

• To demonstrate the safety and efficacy of the SELUTION SLR™ 018 DEB compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).

MOTIV BTK (Active/Enrolling)

• To evaluate the safety and efficacy of the MOTIV scaffold for the treatment of infrapopliteal lesions in patients with critical limb ischemia (CLI) by randomized comparison with standard balloon angioplasty.

RESTOR (Follow-up)

• To demonstrate the safety and effectiveness of the AngioSafe Peripheral CTO Crossing System to facilitate crossing chronic total occlusions (CTOs) in the peripheral arteries of lower limbs.

Veritas (Active/Enrolling)

• To collect comparative evidence on patient reported outcomes of Varithena compared to ETA when used to treat the incompetent great saphenous vein (GSV). ETA will include either radiofrequency ablation or endovenous laser ablation according to the site’s standard practice. To provide long term (1-year, 2-year, and 3-year) outcomes.

CIS Lafayette General Southwest

Bolt (Active/ Enrolling)

• The objective of this study is to demonstrate the safety and efficacy of the Indigo Aspiration system for percutaneous mechanical thrombectomy in a population presenting with obstruction due to deep vein thrombosis (DVT) who are eligible for treatment.

CIS Houma

Empower (Active/Enrolling)

• The primary objective of the study is to evaluate the safety of deploying and implanting the Carillon device in the coronary sinus/great cardiac vein in patients with functional mitral regurgitation.

EXPAND TAVR (Active/Enrolling)

• The primary safety objective is to demonstrate that the composite rate of all-cause mortality, all stroke, life-threatening or fatal bleeding (BARC Type 3 or 4), acute kidney injury (VARC 3 – Stage IV), hospitalization due to device or procedure-related complication, or valve dysfunction requiring reintervention at 30 days in the device arm is less than the performance goal.

SURTAVI (Follow-up)

• 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 (Follow-up)

• 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.

Triluminate (Active/Enrolling)

• The objective of this trial is to evaluate the safety and effectiveness of the TripClipTM device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR) who have been determined by the site’s local heart team to be at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery.

J-Valve (Active/Enrolling)

• The main objective of this EFS is to assess the preliminary safety and effectiveness of the JC Medical J-Valve TF System in patients with symptomatic severe native AR who are judged by a multi-disciplinary heart team to be eligible for the device and to be at high risk for open surgical aortic valve replacement

CIS Houma

Occluflex (Active/Enrolling)

• The objective of this study is to investigate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore® Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke, and device/procedure related SAEs