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95 active trials for Peripheral Artery Disease

Investigating the Safety and Efficacy of the Treatment With the Non-compliant Jade Balloon in TASC C and D Athero-occlusive Infra-inguinal Disease in Patients With Chronic Limb Threatening Limb Ischemia From SingaporE

The objective of this clinical study is to evaluate the 6-month safety and performance outcome of the non-compliant high pressure JADE balloon for the treatment of infrainguinal stenotic occlusive or stenotic TASC C & D lesions in patients with chronic limb threatening ischemia.

Start: August 2020

Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.

Patients with lower extremity peripheral artery disease (PAD) are at risk of developing major adverse limb events and have a similar cardiovascular (CV) morbidity and mortality to those with coronary artery disease (CAD) with which is associated in most cases with a more severe prognosis. Because of higher risk conferred by concomitant PAD an early diagnosis is recommended in subjects with CAD. PAD can be diagnosed relatively easily and noninvasively with the ankle-brachial index (ABI) measure. An ABI ?0.9 is an indicator of the presence of lower extremity PAD, indicating athero-occlusive arterial disease while >1.3/1.4 indicates an incompressible ankle arteries. However, ABI is not routinely applied in the clinical practice. Data on prevalence of PAD are scanty and in patients with stable CAD are lacking. The under-diagnosis of PAD may be a barrier to the use of treatments to improve prognosis. The primary aim of this study is to assess the coexistence of PAD in subjects with stable CAD and to evaluate the management and the prognosis of these patients in primary care at 12-month after the inclusion in the study.

Start: September 2019

Gamification-Augmented Home-Based Exercise for Peripheral Artery Disease

A randomized trial of a gamification-enhanced home-based walking program compared with a standard home-based walking program in patients with intermittent claudication. Patients will be provided with a Fitbit device and set an exercise goal. Over the next 16 weeks, patients will receive text message reminders to exercise and daily steps will be tracked. Half of patients will be randomized to a gamified interface that leverages behavioral economic principles to encourage exercise.

Start: October 2020

Synergistic Influence of Rivaroxaban on Inflammation and Coagulation Biomarkers in Patients With CAD and PAD on Aspirin Therapy

This is a phase IV, prospective biomarker study that will be conducted at Sinai Hospital of Baltimore. After screening for patients who were treated with aspirin, thirty patients will be treated with 81 mg enteric coated (EC) aspirin for 7 days in the "lead-in" period and then will be randomly treated with EC aspirin (81mg qd) or EC aspirin (81mg qd) plus rivaroxaban (2.5 mg bid) for 12 weeks. Platelet aggregation, soluble markers of platelet activation and inflammation, thrombin generation kinetics and tissue factor (TF)-induced platelet-fibrin clot strength will be assessed at baseline (after 7 days of treatment with 81 mg EC aspirin), and 4 and 12 weeks after randomization of the study drug administration.

Start: January 2020

Low InTensity Exercise Intervention in PAD

This proposed study will determine whether a home-based exercise intervention that avoids continuous supervision and exercise-related ischemic pain improves walking performance at 52-week follow-up in people with PAD, compared to an attention control group and compared to a high intensity exercise intervention. In our secondary aims, we will determine whether high intensity exercise improves six-minute walk distance as compared to the attention control group. In secondary aims, we will also determine whether low intensity exercise and high intensity home-based exercise, respectively, improve patient reported outcomes, physical activity, and treadmill walking performance compared to attention control. Our intervention directly addresses two aspects of current practice guidelines that are major barriers to exercise for patients with PAD: 1) the recommendation for supervised exercise and 2) the recommendation for high intensity ischemic-pain inducing walking exercise.

Start: June 2015

Improve PAD PERformance With METformin

The PERMET trial will determine whether metformin daily for six months improves six-minute walk performance in individuals with peripheral artery disease compared to placebo.

Start: May 2017

ABLUMINUS DES BTK Registry - FIM

A prospective, single center, single arm non-randomized trial collecting safety and effectiveness data for the ABLUMINUS DES System to treat BTK lesions in subjects with CLI.

Start: August 2020

Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance

Among patients awaiting cardiac surgery, a significant proportion are patients with severe angina, heart failure (HF) and peripheral atherosclerosis. These factors are predictors of an unfavorable near and long-term prognosis after open cardiac surgery. It is known that the restriction of motor activity in patients with peripheral atherosclerosis and HF leads to loss of muscle mass, as well as to a decrease in its strength and endurance: secondary (disuse) sarcopenia is formed. In patients with peripheral atherosclerosis and HF, the low functional status of skeletal muscles is associated with a poor prognosis, regardless of gender, age, and concomitant coronary artery disease. A number of studies have shown that the deterioration of muscle status before abdominal, orthopedic and vascular surgery interferes with the close results of surgery, increases the number of complications, the length of ICU and in-hospital stay. Thus, sarcopenia serves as an additional factor worsening the prognosis. Therefore, efforts aimed at improving the functional status in patients planning an open cardiosurgical surgery seem to be very justified. Standard preoperative management of patients includes the identification and correction of comorbidities and the optimal medical treatment. The idea of "rehabilitation" means an additional improvement in the functional capabilities of patients awaiting surgery. Prevention includes outpatient outreach and educational work by nurses, as well as preoperative physical exercises. For this, multi-level training is used: respiratory exercises for the patients with the most severe illness, free movements of the limbs without load, or bike or treadmill training with increasing load for tolerable patients. However, adequate physical rehabilitation is difficult particularly on an outpatient basis. Low adherence is due in part to inadequate strength and inability to tolerate or sustain even low levels of activity due to angina, chronic lower limb ischemia and heart failure symptoms. In this study, the investigators propose to use neuromuscular electrical stimulation (NMES) to assist patient initiation of quadriceps strengthening in order to progressively increase low exercise tolerance.

Start: September 2020

REvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study

This is an observational study of the DABRA Laser System and other medical devices intended for endovascular treatment of peripheral artery disease.

Start: May 2019

Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study

The objective of this observational registry is to track the clinical progression of chronic limb-threatening ischemia (CLTI) and incidence of death, amputation, and revascularization attempts over a one-year period.

Start: February 2020

In-Stent Restenosis Post-Approval Study

The objective of the ISR 14-04 study is to evaluate post-market safety and effectiveness of GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the Superficial Femoral Artery.

Start: September 2015

Lactate Increase in Peripheral Artery Disease

To our knowledge, the measurement of the transcutaneous oxygen pressure during walking is the only continuous method that estimates the importance of ischemia, bilaterally and segment of limb by segment of limb. The determination of the lactates concentration, with micro method from earlobe sampling, is very widely validated in physiology and exercise physiopathology; and it is widely used, by laboratories, for exercise investigation in athletes. We use it in routine to evaluate the presence of functional limitation during tcpO2 tests on a treadmill. The present study hypothesises a significant relationship between lactatemia variation (difference between lactatemia after 3 minutes of recovery from walking and the value at rest) and tcpO2 "decrease from rest of oxygen pressure (DROP) values for patients with peripheral artery disease (PAD).

Start: October 2017

Treatment of Patients With Lesions in the Superficial Femoral or Popliteal Arteries Using Kanshas Drug Coated Balloon

To assess safety and efficacy of the Kanshas DCB in the treatment of de novo lesions in the superficial femoral (SFA) and/or popliteal arteries.

Start: April 2017

Static Muscular Stretching for Treatment of PAD

Patients with peripheral arterial disease (PAD) often have walking impairment due to insufficient oxygen supply to skeletal muscle. The investigator's pilot study in PAD patients has shown that endothelial function and walking distance improve with regular static muscle stretching. Therefore, the purpose of this study is to determine whether prescriptive muscle stretching improves muscle oxygenation and walking ability in PAD patients. This is a single-blinded study in 40 patients with stable symptomatic PAD. Patients assigned to the stretch group will use ankle splints (both legs) to perform static muscle stretching for 4 weeks (ankle dorsiflexion applied 30 min/d, 5 days/wk). Patients assigned to the control group will also wear the ankle splints daily but without invoking any dorsiflexion, i.e., without stretching. Measurements will consist of ankle-brachial index (ABI) at rest and post-exercise, skeletal muscle oxygenation (evaluated with near-infrared spectroscopy (NIRS)), and 6 minute walk test (6MWT), performed at baseline and after 4 weeks of stretching (or control splint placement). In addition, NIRS will be used to evaluate muscle oxygenation while patients are wearing the splint device in order to quantitatively prescribe the angle of dorsiflexion that provides optimum stretch and deoxygenation of the calf muscles without causing pain. Primary outcomes include increased muscle oxygenation during exercise and walking distance after 4 weeks of static muscle stretching. Results from this study will be used to support funding applications for a larger efficacy trial.

Start: July 2020

Telmisartan Plus Exercise to Improve Functioning in Peripheral Artery Disease

The TELEX trial will establish whether telmisartan alone improves walking performance in people with peripheral artery disease (PAD). The TELEX trial will also determine whether telmisartan plus supervised exercise improves walking performance more than either therapy alone. TELEX is a randomized controlled clinical trial (2 x 2 factorial design) of 112 participants with PAD randomized to one of four arms: Group A: telmisartan + supervised exercise therapy; Group B: telmisartan + a "no exercise" control group; Group C: placebo + supervised exercise therapy; and Group D: placebo + a "no exercise" control group.

Start: October 2015

Unacylated Ghrelin to Improve Functioning in PAD

GIFT is a pilot, randomized, double-blinded clinical trial that will examine the effects of unacylated ghrelin on walking ability in people with peripheral artery disease (PAD) compared to placebo. Preliminary evidence suggests that unacylated ghrelin may improve blood flow to the extremities and promote improved skeletal muscle growth and energy use. A total of 30 participants with PAD will be randomized to one of two groups: unacylated ghrelin injections or placebo injections . Participants will self-administer the study drug or placebo subcutaneously once daily for four months. The primary outcome is change in six-minute walk distance between baseline and 4-month follow-up

Start: September 2020

Intermittent Pneumatic Compression With and Without Exercise to Improve Functioning in Peripheral Artery Disease

The INTERCEDE randomized trial will establish whether six-months of intermittent pneumatic compression combined with walking exercise improves walking endurance at six-month follow-up, compared to walking exercise + sham compression therapy, in people with lower extremity peripheral artery disease (PAD). The INTERCEDE trial will also determine whether intermittent pneumatic compression therapy improves walking endurance at 6-month follow-up, compared to a sham compression therapy. The trial will also determine whether benefits of intermittent pneumatic compression persist after intermittent pneumatic compression treatment is completed.

Start: January 2019

Platelet Reactivity in PAD Undergoing Percutaneous Angioplasty

Dual antiplatelet therapy has a key role in a prevention of thrombosis of treated artery in patients undergoing percutaneous transluminal angioplasty (PTA). Weak therapeutic response and presence of residual platelet activity is related to high risk for stent thrombosis and it is well in known in coronary artery disease (CAD) patients undergoing percutaneous coronary intervention (PCI). However there are few data on the association between a different entity of platelet inhibition on antiplatelet treatment and clinical outcomes in patients with peripheral artery disease (PAD). The aim of this study was to evaluate the degree of on-treatment platelet reactivity, and its association with ischemic and hemorrhagic adverse events at follow up in PAD patients undergoing PTA.

Start: January 2020

Dysvascular Amputation Self-Management of Health

The purpose of this study is to determine if walking biobehavioral intervention improves physical activity after dysvascular lower limb amputation.

Start: November 2019

The Value of Screening for HPR in Patients Undergoing Lower Extremity Arterial Endovascular Interventions

This is a randomized controlled trial designed to evaluate the role of screening for and intervening on patients with high on treatment platelet reactivity undergoing lower extremity arterial endovascular interventions.

Start: August 2019