Cardiovascular Research Trials

None at this time.

None at this time.

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.

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 Houma

Elevate HF (Pending)

• Assess the safety of dual chamber physiological pacing therapy in people with HFpEF.

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).

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).

THRIVE (Active/Enrolling)

• The primary objective of the THRIVE Pivotal study is to demonstrate the adjunctive effectiveness and the safety of the TIVUS system in: a) subjects with uncontrolled hypertension (HTN) receiving up to 2 anti-hypertensive drugs of different classes in whom the anti-hypertensive medications will be stopped for a 4-week wash-out period before RDN/Sham procedure and during 2 months after procedure. b) subjects with controlled hypertension receiving up to 2 anti-hypertensive drugs of different classes and who accept to be off-medications for a 4-week wash-out period before RDN/Sham procedure and 2 months after the procedure.

CIS Lafayette

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

SELUTION4DeNovo (Pending)

• To demonstrate the safety and efficacy of the SELUTION SLR DEB for treatment of de novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of 2.00 mm to 2.75 mm, in support of a pre-market approval (PMA) application to the United States (US) FDA.

Elite BTK (Active/Enrolling)

• The trial evaluates the safety and efficacy of the MAGNITUDE® S-BRS in the treatment of chronic limb-threatening ischemia due to de novo or restenotic lesions in the infrapopliteal arteries compared to standard PTA alone.

Ambition (Active/Enrolling)

• The objective of the randomized study is to assess the safety and effectiveness of Auryon laser treatment used in combination with standard balloon angioplasty versus standard balloon angioplasty alone to treat infrapopliteal lesions in subjects with critical limb ischemia.

Boomerang (Active/Enrolling)

• The objective of this Pivotal Study is to evaluate the safety and effectiveness of the Boomerang Catheter for percutaneous deep venous arterialization (pDVA).

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).

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.

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 (Active/Enrolling)

• 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.

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.

TRICAV (Active/Enrolling)

• 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.