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Peripheral Arterial Disease clinical trials

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NCT ID: NCT03188341 Completed - Clinical trials for Peripheral Arterial Disease

Cardiac Complication After Vascular Surgery

CCVS
Start date: December 2010
Phase: N/A
Study type: Observational

The vascular surgery is a highest risk procedure when considering postoperative complications associated with the cardiovascular system. The leading clinical presentation is acute hemodynamic decompensation. However, one of the possible pathomechanisms might be repolarization disturbances. Many of perioperative risk factors of cardiac complications are modifiable. The identification may help in the global perioperative risk reduction. Aim: The aim of the study was an identification of the factors which may release clinically overt repolarization disturbances. Methods: The study group consisted of 100 patients, diagnosed with abdominal subrenal aortic aneurysms or peripheral arterial disease scheduled for an elective "open" vascular surgery procedure. The authors investigated whether age, gender, comorbidities or some perioperative factors (including hemodynamic, metabolic or genetic) were related to the occurrence of clinically concealed repolarization disturbances or clinically disclosed cardiac complications in postoperative time up to 30 day and one year after vascular surgery procedure.

NCT ID: NCT03185052 Completed - Clinical trials for Peripheral Arterial Disease

Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach

FREEDOM OP
Start date: September 27, 2017
Phase: N/A
Study type: Interventional

Over the past years, arterial closure systems have tended to replace manual compression to ensure hemostasis at femoral artery puncture points. Arterial closure systems reduce hemostasis and patient immobilization times, thus enabling early resumption of walking. These devices have contributed extensively to the development of outpatient stays for cardiology, vascular and neuro-radiology procedures. According to certain studies however, it would appear that arterial closure devices do not present any greater benefits than manual compression in terms of hemostasis and complications. Moreover, the use of increasingly small diameter instruments would tend to render manual compression sufficient. Finally, the use of these devices generates additional costs. The purpose of our prospective study is to evaluate the feasibility and safety of same-day discharge after manual compression in patients treated for peripheral artery disease by endovascular technique with 5F sheath.

NCT ID: NCT03174990 Completed - Clinical trials for Peripheral Arterial Disease

Aspirin and Thienopyridine Resistance in Peripheral Arterial Disease

Start date: August 31, 2010
Phase: N/A
Study type: Observational

This study evaluates the effects of Aspirin and thienopyridine resistance in relation to clinical cardiovascular outcomes as the genetic predictors of, and outcomes associated with aspirin and thienopyridine resistance in patients with peripheral arterial disease (PAD) currently remain unknown.

NCT ID: NCT03163199 Completed - Clinical trials for Peripheral Arterial Disease

TRanslesIonal Assessment of Gradients During Endovascular Therapy

TRIAGE
Start date: April 12, 2017
Phase:
Study type: Observational

Primary objective: To document change in translesional pressure gradients (TLPGs) and ratios (fractional flow reserve) using the NAVVUS RXi catheter following endovascular treatment for symptomatic lower extremity peripheral arterial disease. Secondary objectives: - Evaluation of correlation of the ABI and TBI and TLPGs at baseline and following endovascular therapy - Evaluation of the correlation between the change in WIQ, TCOMs, wound size and change in TLPGS - Evaluation of correlation between lesion severity by QVA (MLD, % diameter stenosis) and TLPGs - Evaluation of baseline MLA, MLD, plaque burden by intravascular ultrasound (optional) and TLPGs

NCT ID: NCT03161327 Completed - Hypertension Clinical Trials

Digital Ankle Brachial Index (ABI) as a Screening Tool in Detecting Peripheral Arterial Disease

Start date: July 15, 2017
Phase: N/A
Study type: Interventional

Peripheral artery disease (PAD) affects 8-18 million in the US and is an economic burden, currently estimated to be greater than cancer and heart disease. Older age (> 65 years), smoking, diabetes and kidney diseases are some risk factors associated with PAD and are known to have increased morbidity and mortality.Early detection is critical for mitigating PAD progression. Ankle-brachial index (ABI) testing is recommended by the US Preventative Services Task Force as an affordable and effective screening tool for evaluating PAD risk. QuantaFlo™ (Semler Scientific, Inc.) is a novel, noninvasive, 510K FDA approved digital device that is used as a screening tool to measure ABI of patients at risk of PAD. This single center prospective clinical trial will evaluate the sensitivity and specificity of digital ABI in detecting PAD using color Doppler ultrasound and 'gold standard' angiography as reference. Specifically in patient undergoing dialysis and who cannot undergo ABI using pressure cuffs dialysis grafts/ fistulae in the arms, we will evaluate the value of digital ABI in detecting PAD.

NCT ID: NCT03148808 Completed - Clinical trials for Peripheral Arterial Disease

Natural Vascular Scaffold (NVS) Therapy

Start date: May 25, 2017
Phase: Phase 1
Study type: Interventional

The NVS Therapy is being studied to evaluate the safety and efficacy of retention of acute luminal gain, leading to acute hemodynamic improvement in superficial femoral and popliteal arteries with reference vessel diameters between 3.5 and 7.0 mm and lesion lengths between 36 and 96mm. The system is intended for use in patients with de novo lesions in the superficial femoral and proximal popliteal arteries.

NCT ID: NCT03099369 Completed - Clinical trials for Peripheral Artery Disease

Daily Step-based Exercise Using Fitness Monitors for Peripheral Artery Disease

EASY FIT
Start date: June 1, 2017
Phase: N/A
Study type: Interventional

Peripheral artery disease (PAD) is caused by blockages in the leg arteries. PAD limits patients' walking ability and quality of life. For patients with PAD, home exercise programs can improve walking ability and quality of life. In many patient populations, walking more than 5,000 steps a day is associated with better health. Currently, the benefit of walking more than 5,000 steps a day in patients with PAD has not been well studied. The purpose of this clinical trial is to compare two different home exercise programs in patients with PAD: walking at least 5,000 steps a day with the help of fitness monitors vs. walking 45 consecutive minutes for 3 to 5 days a week (a common exercise prescription for PAD). This study has the potential to demonstrate that, with the help of fitness monitors, walking at least 5,000 steps a day can improve walking ability and quality of life for patients with PAD.

NCT ID: NCT03098290 Completed - Quality of Life Clinical Trials

IDOMENEO - Is Treatment Reality in Vascular Medicine Evidence-based and Follows Guideline Recommendations? A Project for Quality Development Exemplified by Peripheral Arterial Disease (PAD)

IDOMENEO
Start date: May 1, 2018
Phase:
Study type: Observational [Patient Registry]

The prevalence of peripheral arterial disease (PAD) and the proportion of endovascular procedures for treatment are increasing worldwide. For many cases of treatment or procedures no randomized controlled trials (RCT) or results from meta-analyses are so far available. The decision for treatment and selection of procedure is therefore not uncommonly left up to the personal expertise of the physician. The IDOMENEO study represents a multistage multimethodological project for healthcare research and quality assurance in interdisciplinary vascular medicine, which undertakes a comprehensive examination of this topic. Various methods and data sources (even routine data) are linked in a meaningful way. The essential components of the total project are implementation of a register platform (GermanVasc), which conforms to data protection and data security as well as the development of instruments for valid measurement of the quality of life of patients with PAD. The data protection-conform linking of primary data in the register and routine data of the consortium partner BARMER should also enable validation of the data sources.

NCT ID: NCT03071146 Completed - Clinical trials for Peripheral Arterial Disease

Utility, Safety, and Effectiveness of the Bard LifeStent 5F Vascular Stent System

REALITY III
Start date: February 15, 2017
Phase:
Study type: Observational

The medical device being examined in this study is the Bard® LifeStent® 5F Vascular Stent System. It is intended for use in patients who suffer from peripheral artery disease (PAD). PAD is generally associated with blocked arteries of the legs. The superficial femoral artery (SFA) and popliteal artery are common locations for this problem to develop. The patient may experience pain or discomfort in the leg that occurs when walking or have other complications associated with wound healing. The purpose of this study is to collect information to assess the deliverability, clinical utility, safety and effectiveness of the Bard® LifeStent® 5F Vascular Stent System.

NCT ID: NCT03068585 Completed - Clinical trials for Peripheral Arterial Disease

Efficiency, Safety and Portability of Neovasculgen

Neovasculgen
Start date: February 2010
Phase: Phase 2/Phase 3
Study type: Interventional

In 2010, we completed a phase 1 to 2a clinical trial of pCMV-vegf165 in patients with chronic lower limb ischemia (stage 2a to 3 according to Fontaine classification modified by A. V. Pokrovsky) who were not suitable for reconstructive surgery or endovascular treatment. This study demonstrated the safety, feasibility, and short-term(3 months) efficacy of pCMV-vegf165 gene transfer,12,13which lead to conducting a phase 2b to 3 multicenter clinical trial. The study was conducted under the control of the Russian Ministry of Health and was completed in 2011. Patients enrolled in the study were subjected to a 6-month