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Vascular Diseases clinical trials

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NCT ID: NCT01182428 Completed - Clinical trials for Coronary Artery Disease

XIENCE V: SPIRIT WOMEN Sub-study

Start date: September 2008
Phase: Phase 4
Study type: Interventional

The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.

NCT ID: NCT01180673 Completed - Hypertension Clinical Trials

Counseling Older Adults to Control Hypertension

COACH
Start date: February 2008
Phase: Phase 3
Study type: Interventional

This study will evaluate the effect of a senior center-based comprehensive therapeutic lifestyle intervention delivered through group-based counseling and motivational interviewing (MINT-TLC) among 250 hypertensive African American or Latino seniors age 60 and older in a randomized control trial.

NCT ID: NCT01179984 Completed - Clinical trials for Peripheral Vascular Disease

Bard® LifeStent® Vascular Stent Delivery System Study

Start date: June 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effectiveness and safety of a new delivery system for the Bard® LifeStent® Vascular Stent System.

NCT ID: NCT01178268 Completed - Clinical trials for Coronary Artery Disease

XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)

Start date: August 2010
Phase: Phase 4
Study type: Interventional

This is a prospective, randomized, active-controlled, open label, parallel two-arm, multi-center, post-approval study descriptively comparing the XIENCE V EECSS to the CYPHER SELECT PLUS Sirolimus-Eluting Coronary Stent System (SECSS) ("CYPHER SELECT PLUS") during commercial use in China.

NCT ID: NCT01173094 Enrolling by invitation - Diabetes Clinical Trials

Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part II) (DCLI-II)

DCLI-II
Start date: August 2010
Phase: Phase 4
Study type: Interventional

The purpose of this trial is to find out the appropriate way to treat DM patients with critical limb ischemia. This trial includes two parts. Part I focuses on the treatment of femoral arterial lesion and part II focuses on the treatment of below-knee arterial lesion.

NCT ID: NCT01171703 Enrolling by invitation - Diabetes Clinical Trials

Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part I)

DCLI-I
Start date: November 2010
Phase: Phase 4
Study type: Interventional

The purpose of this trial is to find out the appropriate way to treat DM patients with critical limb ischemia. This trial includes two parts. Part I focuses on the treatment of femoral arterial lesion and part II focuses on the treatment of below-knee arterial lesion.

NCT ID: NCT01161251 Completed - Atrial Fibrillation Clinical Trials

Atrial Fibrillation Registry for Ankle-brachial Index Prevalence Assessment: Collaborative Italian Study.

ARAPACIS
Start date: July 2010
Phase: N/A
Study type: Observational

Atrial fibrillation (AF) is the most common sustained dysrhythmia encountered in clinical practice in North America and Europe, accounting for approximately one-third of all hospitalizations for a cardiac rhythm abnormality. The presence of AF markedly increases the patient's risk for developing arterial embolism and stroke, depending on the presence of other clinical conditions, such as hypertension and diabetes. AF is associated with a fivefold increased risk for stroke, and is estimated to cause 15% of all strokes. Patients with AF frequently have several risk factors for atherosclerosis, including hypertension, diabetes, and dyslipidemia. Accordingly, systemic signs of atherosclerosis can be detected in AF patients, and these likely accounts for an enhanced risk of coronary heart disease. In addition to cerebrovascular disease, patients with AF may suffer from coronary events including myocardial infarction (MI), but the rate of MI in AF patients seems to be variable, but often underestimated. Moreover, coexistence of peripheral arterial disease (PAD) is a relevant clinical sign of systemic atherosclerosis. Ankle-brachial index (ABI) is a simple, inexpensive, and non-invasive PAD measurement, even at the pre-symptomatic phase when intervention can improve prognosis and prevent or delay severe complications ABI is calculated by measuring the systolic blood pressure in the posterior tibial and/or the dorsalis pedis arteries either in both legs or 1 leg chosen at random (using a Doppler probe or alternative pulse sensor), with the lowest ankle pressure then divided by the brachial systolic blood pressure. In addition to peripheral artery disease, the ABI also is an indicator of generalized atherosclerosis because lower levels have been associated with higher rates of concomitant coronary and cerebrovascular disease, and with the presence of cardiovascular risk factors. Two large studies in patients with AF document the existence of PAD in about 3-5% of patients. It is possible, however, that such an incidence has been underestimated as only symptomatic patients were considered as affected by PAD. As PAD is an important marker of systemic atherosclerosis, its association with AF reinforces the concept that patients with AF have systemic atherosclerosis that potentially account for coronary complications. To date, a national registry of AF patients is not available to verify the real impact of cardiovascular events in this clinical setting.

NCT ID: NCT01158261 Completed - Hemorrhage Clinical Trials

The Evicel Post-Authorization Surveillance Study

Start date: June 2010
Phase: N/A
Study type: Observational

The objective of this non-interventional Post Authorisation Safety Surveillance (PASS) study is to observe the clinical safety performance of EVICEL when used as suture support for haemostasis in vascular surgery.

NCT ID: NCT01157949 Withdrawn - Clinical trials for Cardiac Allograft Vasculopathy

A Study to Compare the Effectiveness of a Drug That Suppresses the Immune System Called Thymoglobulin® in Preventing the Development of a Disease That Affects the Majority of Heart Transplant Recipients Called Cardiac Allograft Vasculopathy (CAV)

Start date: November 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to test the hypothesis that administering Thymoglobulin® induction therapy early after transplant prevents the development of cardiac allograft vasculopathy (CAV). CAV accounts for a significant number of deaths in cardiac recipients after the first year of transplant. At 5 years post-transplant 30% of the deaths are due to CAV. With the exception of re-transplantation the available treatments for CAV are only effective at inhibiting its progression. CAV involves only the allograft and spares the native arteries, suggesting an immunologic basis for the disease. However, both immunological and non-immunological factors contribute to the development of CAV. The established immunological risk factors are recurrent rejection and humoral/antibody-mediated rejection (AMR). Non-immunological risk factors identified include preservation injury, the cause of donor death, donor graft ischemic time, and cytomegalovirus infection1. It is hypothesized that these factors increase the risk of developing CAV by causing early endothelial damage to the graft, which then could promote increased lymphocyte-endothelial interactions and the production of anti-endothelial antibodies2. The investigators hypothesized that Thymoglobulin induction therapy would prevent the development of CAV because its polyclonal nature allows Thymoglobulin to target all the potential mechanisms that contribute to the development of CAV—T-cell activation, B-cell activation, antibody formation, induction of tolerance, and modulation of lymphocyte-endothelium interactions3. Because the mechanism by which Thymoglobulin affects the immune system are still poorly understood, the investigators will also study how Thymoglobulin changes the immune system over time in the heart transplant recipient as a secondary objective.

NCT ID: NCT01154751 Terminated - Clinical trials for Peripheral Artery Disease

Data Registry Following Patients Using Supera Stent in the Femoral Arteries

STRONG
Start date: November 2008
Phase: N/A
Study type: Interventional

Long-term, observational, prospective, multicenter registry following patients who have been implanted with the SUPERA Interwoven Self-Expanding Nitinol Stent for treating stenosis in the superficial femoral and/or femoropopliteal arteries.