Adjuvant Benefit of NMES to Supervised Exercise in Patients With IC
Intermittent ClaudicationPeripheral Vascular Disease1 moreThis study will assess the adjuvant benefit of a neuromuscular electrical stimulation device to standard treatment of supervised exercise in patients suffering from symptoms and effects of lower limb Intermittent Claudication.
Standard Versus PICO Dressings in Lower-Extremity Bypass Patients
Of Bypass Graft of the ExtremitiesPeripheral Arterial Disease2 moreThe objective of this study is to compare the effectiveness of standard moist dressings and PICO single-use negative pressure dressings in post-operative lower extremity bypass patients. This study will compare the dressings' ability to decrease swelling, decrease post-operative infection, and improve mobility and quality of life measures. Subjects will be asked to participate in this study because they will undergo a lower extremity bypass using the ipsilateral great saphenous vein. Subjects will then be randomized to two post-operative treatment groups. One group will receive standard sterile gauze and the other will receive PICO single-use negative pressure dressings. Both groups will be assessed for study measures in follow-up visits as clinically indicated up to 1 year with the 30 day timepoint as the primary outcome for study measures.
Comparison of the SUpera® PERipheral System in the Superficial Femoral Artery
Peripheral Vascular DiseaseThis is a prospective, multicenter, non-randomized, single arm, pivotal trial. The main objective of this study is to demonstrate the safety and effectiveness of the IDev SUPERA® Nitinol Stent System in treating subjects with obstructive superficial femoral artery (SFA) disease. The primary endpoint will be the primary patency of the SFA evaluated at 12 months. The outcome will be compared to a performance goal based on clinical trials of percutaneous transvenous angioplasty (PTA) alone.
Bard® LifeStent® Vascular Stent Delivery System Study
Peripheral Vascular DiseaseThe purpose of this study is to evaluate the effectiveness and safety of a new delivery system for the Bard® LifeStent® Vascular Stent System.
The Jetstream G3™ Calcium Study
Peripheral Arterial DiseaseTo investigate the treatment effects with the Jetstream G3 System in moderate to severely calcified peripheral artery disease in the common femoral, superficial femoral or popliteal arteries using intravascular ultrasound (IVUS).
Motivational Interviewing (MI) for African Americans With Peripheral Arterial Disease (PAD)
Peripheral Arterial DiseaseThe investigators are conducting a clinical research trial to determine the role of motivational interviewing (MI) on promoting home-based walking therapy to improve walking ability in African Americans with peripheral arterial disease (PAD). African Americans are more than two times as likely as non-Hispanic whites to suffer from PAD. For patients with PAD, there is a significant risk for poor walking ability and limb loss. One major treatment for PAD is walking therapy but the traditional methods for the delivery of this treatment have required frequent visits to a university or hospital-based site. The investigators will address the role of self-managed walking program, to be conducted at or near the home, to improve limb function. In order to motivate the participants to walk, the investigators included two different intervention strategies: MI and patient-centered counseling for exercise (PACE). The investigators hypothesize that participants randomized to the MI arm will have a greater increase in their walking distance, compared to those receiving Patient-Centered Assessment and Counseling for Exercise (PACE) and the control group.
Cardiac Remote Ischemic Preconditioning Before Elective Major Vascular Surgery
Peripheral Arterial DiseaseVascular surgery is considered a high-risk operation with an anticipated risk of major cardiovascular complications in excess of 5%. The occurrence of a cardiovascular complication after surgery carries a long-term higher mortality risk. The main objective of this investigation is to reduce the proportion of patients having major cardiovascular complications during surgery through a clinical protocol of remote preconditioning that is safe, effective and reproducible.
Study to Compare 2 Doses of Polycap Versus Single Dose of Polycap With or Without Pottasium
Ischemic Heart DiseaseIschemic Stroke2 moreThis is a randomized double blind 2x2 factorial controlled trial to evaluate efficacy tolerability of low strength Polycap versus two doses of low strength Polycap in patients with stable cardiovascular disease in reducing blood pressure and LDL. To evaluate the tolerability and safety of low dose potassium supplementation compared to placebo in patients with stable cardiovascular disease. Approximately 500 patients are planned to be randomized.
Phase IIa: Safety, PK, & Tolerability of Sodium Nitrite in Patients With Peripheral Arterial Disease-SONIC...
Peripheral Arterial DiseaseSodium nitrite has been demonstrated to promote new blood vessel growth, speed up wound healing and prevent tissue necrosis in animals. Since patients with PAD experience many of these problems, this study will seek to determine whether this drug, when given orally, could provide the same benefits to patients with PAD.
Efficacity Study With the Protégé EverFlex Stent in Popliteal Lesions
Peripheral Arterial DiseaseThis study will assess the results up to 12 months with the Protégé EverFlex stent (ev3) in patients presenting with a narrowing or blocking at the level of the knee artery, which leads to a limited walking distance, rest pain or non-healing ulcers.