Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
General Inclusion Criteria:
- Patient is ≥35 years old.
- Stenosis ≥70% by catheter angiography (NASCET Criteria) OR by DUS with ≥70% stenosis defined by a peak systolic velocity of at least 230 cm/s plus at least one of the following:
- an end diastolic velocity ≥100 cm/s, or
- internal carotid/common carotid artery peak systolic velocity ratio ≥4.0, or
- CTA with ≥ 70% stenosis, or
- MRA with ≥ 70% stenosis.
- No medical history of stroke or TIA
Vascular Outcomes study of ASA along with Rivaroxaban in Endovascular or surgical limb Revascularization for peripheral artery disease (PAD)
General Inclusion Criteria:
- Age ≥ 50
- Documented moderate to severe symptomatic lower extremity atherosclerotic peripheral artery disease as evidenced by ALL of the following:
- clinically, by functional limitations in walking activity, ischemic rest pain, or ischemic ulceration
- anatomically, by imaging evidence of peripheral artery disease distal to the external iliac artery in the index leg within 12 months prior to or at the time of the qualifying Revascularization
CHAMP HF Study
Observational Registry of Treatment Patterns in U.S. Heart Failure Patients with Reduced Ejection Fraction
General Inclusion Criteria:
- > 18 years of age
- CHF diagnosis
- EF < 40% (last 12 months)
- On at least 1 heart failure medication
A Prospective, Multicenter, Single Arm, Real-World Registry Assessing the Clinical Use of the Lutonix® 035 Drug Coated Balloon (DCB) Catheter in Arteries of the Superficial Femoral Artery (SFA)and Popliteal Artery (PA)
General Inclusion Criteria:
- The subject agrees to comply with the protocol-mandated follow-up procedures and visits.
- The subject is ≥ 21 years old.
- The subject must have a lesion(s) that can be treated with available Lutonix® 035 DCB Catheter according to the Instructions For Use (IFU).
Ascension Seton heart valve clinic is the first site in Central Texas to participate in a groundbreaking study of the potential benefits of MitraClip®, a catheter-based, minimally invasive treatment option that can help patients with severe mitral regurgitation.
Click to play animation of the MitraClip® procedure.
Patients are randomized into two groups: 1) MitraClip® procedure or 2) continued medical therapy.
For more information, contact the Seton Heart Institute Research Program: (512) 324-3434
Absorb III Randomized Controlled Trial (RCT)
Objective: The pivotal trial to support the US pre-market approval (PMA) of Absorb BVS. ABSORB III will evaluate the safety and effectiveness of the Absorb BVS System compared to the XIENCE in the treatment of subjects, including those with diabetes mellitus, with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.
General inclusion Criteria:
- Subject must be at least 18 years of age to participate in clinical research.
- Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
- Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective PCI. Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objectives sign of ischemia as determined by one of the following, echocardiogram, nuclear scan, ambulatory ECG or stress ECG). In the absence of noninvasive ischemia, FFR must be done and indicative of ischemia.
- Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
- Female subject of childbearing potential who does not plan pregnancy for up to 1 year following the index procedure. For a female subject of childbearing potential a pregnancy test must be performed with negative results known within 7 days prior to the index procedure per site standard.
- Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.
- Subject agrees to not participate in any other investigational or invasive clinical study for a period of 1 year following the index procedure.
Research in followup/closed to enrollment
Takeda Study – A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate Cardiovascular Outcomes of TAK-875, 50 mg in Addition to Standard of Care in Subjects with Type 2 Diabetes and with Cardiovascular Disease or Multiple Risk Factors for Cardiovascular Events”, TAK-875_306.
St. Jude Medical – LAPTOP-HF – Randomized trial to evaluate whether using physician-directed, patient self-management system guided by left atrial pressure measurements, can improve outcomes in patients with heart failure.
Abbott – ACT 1- A Randomized, Controlled Trial to Demonstrate the Equivalence of Carotid artery Stenting using the Xact RX Carotid Stent System with the Emboshield Cerebral Protection System when Compared to Carotid Endarterectomy of Asymptomatic Extracranial Occlusive Disease.
Cordis – ELITE – A Prospective, Single-Blind, Randomized, Multi-Center Study Comparing the CYPHER ELITE to the CYPHER Bx VELOCITY Sirolimus-Eluting Stent Systems.
Abbott – XIENCE V – XIENCETM V Everolimus Eluting Coronary Stent System (EECSS) USA Post-Approval Study.
Medtronic – RESOLUTE – Clinical Evaluation of the Medtronic Endeavor Resolute Zotarolimus-Eluting Coronary Stent System in the Treatment of De Novo Native Lesions in Native Coronary Arteries with the Reference Vessel Diameter of 2.25mm to 4.2mm.
Abbott – MOBILITY – A Prospective, Non-Randomized, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of the Absolute ProTM Peripheral Self-Expanding Stent System in Subjects with Atherosclerotic De Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery.
Medtronic – Complete SE SFA – The Medtronic Complete Self-Expanding (SE) SFA stent for the treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery
HCRI – DAPT – A Prospective, Multi-Center, Randomized, Double-Blind Trial to Assess the Effectiveness and Safety of 12 versus 30 months of Dual Antiplatelet Therapy (DAPT) in subjects undergoing Percutaneous Coronary Intervention (PCI) with Either Drug Eluting Stent (DES) or Bare Metal Stent (BMS) Placement for the Treatment of Coronary Artery Lesions”.
Eli Lilly – The Trilogy ACS Study – A Comparison of Prasugrel and Clopidogrel in Acute Coronary Syndrome (ACS) Subjects with Unstable Angina/ Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) who are Medically Managed.
Medtronic – EDUCATE – Endeavor Drug Eluting Stenting: Understanding Care, Antiplatelet agents and Thrombotic Events.
Roche – ALECARDIO – Cardiovascular outcomes study to evaluate the potential of Aleglitazar to reduce cardiovascular risk in patients with a recent acute coronary syndrome event and type 2 diabetes mellitus.
CANOPY – Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy – Study to assess the performance outcone of the RX Acculink Stent system under commercial use in patients at standard risk for adverse events from CEA
MOMENTUM Study – A clinical trial to evaluate the safety and effectiveness of the ABSOLUTE PRO® peripheral self-expanding stent system and the ABSOLUTE PRO® LL peripheral self-expanding stent system in the treatment of subjects with atherosclerotic de novo or restenotic leasions in the native superficial femoral artery and/or native proximal popliteal artery.
PROMISE Trial – Prospective Multicenter Imaging Study for Evaluation of Chest Pain – Study to determine whether the information derived from an anatomic imaging strategy (CTA) as compared to a functional testing strategy will provide superior clinical outcome in pts with symptoms concerning for CAD
EUCLID (Examining Use of tiCagreLor In paD) Study – A study to compare ticagrelor (Brilinta) with clopidogrel (Plavix) treatment on the risk of cardiovascular death, myocardial infarction and ischemic stroke in patients with established Peripheral Artery Disease (PAD).
ORBIT-AF II Study – Outcomes Registry for Better Informed Treatment of Atrial Fibrillation. Study of patients 21 years of age or older with a new diagnosis of Atrial Fibrillation within the past 6 months and currently taking a novel oral anticoagulant that has been started within the past 3 months.