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)

Victorian 1 Prevent (Follow-up)

• 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)

Horizon Expansion (Active/Enrolling)

• Demonstrate superiority of pelacarsen (TQJ230) compared to placebo in lowering the Lp(a) level at 12 months of treatment in US Black/African American and US Hispanic participants with established ASCVD and a plasma Lp(a) level of ≥ 125 nmol/L

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

COSIRA (Active/Enrolling)

• To demonstrate the safety and effectiveness of the Reducer system for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization.

Librexia ACS (Active/Enrolling)

• To demonstrate that milvexian is superior to placebo, in addition to standard-of-care, in reducing the risk of MACE (the composite of CV death, MI, and ischemic stroke)

CIS Lafayette General

Dal GenE-2 (Active/Enrolling)

• The primary objective of this trial is to evaluate the potential of dalcetrapib to reduce the occurrence of fatal and non-fatal myocardial infarction in subjects with a documented recent ACS and the AA genotype at variant rs1967309 in the ADCY9 gene.

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

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.

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 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.

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).

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

OSPREY (Follow-up)

• 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 (Follow-up)

• 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).

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.

THOR (Active/Enrolling)

• The study is intended to evaluate the safety and efficacy of the Thor System in the treatment of de novo calcified lesions in native intralingual arteries in patients with peripheral artery disease (PAD).

Great Trial (Active/Enrolling)

• The objective of this study is to establish reasonable assurance of safety and effectiveness to support a 510(k) submission for the Golazo Peripheral Atherectomy System as indicated.

CIS Houma

THOR (Active/Enrolling)

• The study is intended to evaluate the safety and efficacy of the Thor System in the treatment of de novo calcified lesions in native infrainguinal arteries in patients with peripheral artery disease (PAD).

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).

FreeFlow (Active/Enrolling)

• To gather data on the safety, crossing efficacy, performance attributes, and clinical results for the FastWire device in patients with CTOs and RC 3-5 LEAD

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.

Agility (Active/Enrolling)

• The objective of this study is to assess the safety and effectiveness of the BD™ LPVCS for the treatment of stenosis and occlusion in the common and/or external iliac artery and the superficial femoral artery (SFA)/proximal popliteal artery (PPA).

GREAT Trial (Active/Enrolling)

• The objective of this study is to establish reasonable assurance of safety and effectiveness to support a 510(k) submission for the Golazo Peripheral Atherectomy System as indicated.

TANGO (PENDING)

• Demonstrate reduction in the composite incidence of ischemia driven major amputation, clinically driven target lesion revascularization and clinically relevant target lesion occlusion at 6 months after the index procedure.

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 (Follow-up)

• 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 (Follow-Up)

• 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

Journey (Active/Enrolling)

• The primary objective of this study is to assess the safety and efficacy of the J-Valve Transfemoral (TF) System in patients with symptomatic, severe (grade 3 or 4), native aortic valve regurgitation (AR) and AR-dominant mixed aortic valve disease, who are judged by a multi-disciplinary heart team to be at high risk for open surgical aortic valve replacement (SAVR).

ATLAS – Altavalve Pivotal (Active/Enrolling)

• The objective of the trial is to assess the safety and effectiveness of the AltaValve System for the treatment of MR in a targeted patient population.

EMBLOK (Active/Enrolling)

• To evaluate the safety, effectiveness, and performance of the EMBLOK EPS during TAVR by randomized comparison with a commercially available embolic protection device.

TRICAV (PENDING)

• To evaluate the safety and effectiveness of the TricValve® Transcatheter Bicaval Valve System for improving outcomes in symptomatic subjects with severe TR deemed by the local Heart Team to be at high risk for tricuspid valve surgery

CIS Lafayette

COMPLETE TAVR (Active/Enrolling)

• To determine whether, on a background of guideline-directed medical therapy, a strategy of complete revascularization involving PCI using drug eluting stents to treat all suitable coronary artery lesions is superior to a strategy of medical therapy alone in reducing the composite outcome of Cardiovascular Death, New Myocardial Infarction, Ischemia-Driven Revascularization or Hospitalization for Unstable Angina or Hospitalization for Heart Failure in patients selected to undergo elective transfemoral TAVR with a balloon expandable transcatheter heart valve (Edwards Lifesciences, Irvine, CA).

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

SPIRARE (PENDING)

• Evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System for mechanical aspiration thrombectomy in the treatment of acute pulmonary embolism (PE).