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BIOFLOW-V: BIOTRONIK * A Prospective Randomized Multicenter Study to Assess the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions * V

To assess the safety and efficacy of the Orsiro Sirolimus Eluting Coronary Stent System in the treatment of subjects with up to three native de novo or restenotic (standard PTCA only) coronary artery lesions compared to the Xience coronary stent…

Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an
All COmeRs PopulaTion (BIO-RESORT): Randomized Multicenter Trial in an All Comers Population Treated Within thE NeThErlands 3 (TWENTE 3)

The aim of the study is to compare the outcome of two DES with biodegradable polymer coatings separately (Orsiro and Synergy) versus an established third-generation durable polymer DES with proven efficacy and safety (Resolute Integrity) in an all…

A placebo-controlled, double-blind, randomized trial to compare the effect of treatment on plaque burden as determined by intravascular ultrasound and to evaluate the efficacy, pharmacokinetics, safety, and tolerability of MDCO-216 given as multiple weekly infusions in subjects with a recent acute coronary syndrome.

Primary ObjectivesTo evaluate the effect of MDCO-216 treatment on the change in PAV of a target coronary artery as measured by IVUS imaging following five weekly infusions of MDCO-216 (20 mg/kg) compared with placebo in subjects with a recent ACS.…

A Prospective, Multi-Center, Non-randomized, Single arm, Open label, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross* Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions.

The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross* micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting…

BIOTRONIK- *A Prospective, Randomized, Multicenter Study to Assess the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Stent in the Treatment Of Subjects With up to two de novo Coronary Artery Lesions* - IV

To evaluate the safety and effectiveness of Orsiro for the treatment of subjects with up to 2 de novo atherosclerotic coronary artery lesions.

Proof-of-pharmacology clinical trial on a vaccine that elicits a protective humoral immune response against oxidized low density lipoprotein

The aim of the present study is to determine the effect of vaccination on anti-oxLDL antibodies in man.

A placebo-controlled, double-blind, randomized trial to compare the effect of different doses of ALN-PCSSC given as single or multiple subcutaneous injections in subjects with high cardiovascular risk and elevated LDL-C.

PRIMARY OBJECTIVE The primary objective of this study is to evaluate the effect of ALN-PCSSC treatment on LDL-C levels at Day 180. SECONDARY OBJECTIVESThe secondary objectives of this study are to evaluate the effect of ALN-PCSSC on the following…

MODULATION OF POSTPRANDIAL LIPEMIA, INFLAMMATION, AND VASCULAR FUNCTION BY PCSK9 INHIBITION IN DIABETES.

To explore the inflammatory changes of a PCSK-9 inhibitor compared with placebo on postprandial lipemia and postprandial leukocyte activation, oxidative stress and endothelial function in men with type 2 diabetes mellitus.

Stenting of symptomatic vertebral artery stenosis. A randomised safety and feasibility study

The primary aim of the proposed study is to assess whether stenting for symptomatic vertebral artery stenosis >= 50% is feasible and safe. A secondary aim is to assess the rate of new vascular events in the territory of the vertebrobasilar…

Effects of ivabradine on vascular function in individuals at increased risk of developing cardiovascular disease and with impaired endothelial function;An international, multicentre, randomised, double-blind, placebo-controlled study over 12 weeks.

The purpose of this study is to demonstrate the beneficial effect of ivabradine on endothelial function in individuals with risk factors for cardiovascular disease and a resting HR * 75 bpm.

Modifying Orphan Disease Evaluation (MODE) Study: A multicenter, open-label study of the
effects of CER-001 on plaque volume in subjects with Homozygous Familial
Hypercholesterolemia

The purpose of the study is to assess the effects of CER-001, given by intravenous infusion with regards to plaque burden of the carotid arteries and the descending thoracic aorta using 3T magnetic resonance imaging (3TMRI).The objective of the…

Evaluation of the subcutaneous administration of 30 mg of S78989 versus placebo and evaluation of the subcutaneous administration of 60mg of S78989 versus placebo, on the reduction of arterial wall inflammation in patients with marked atherosclerotic plaque inflammation.
A 28-weeks, randomized, double-blind, parallel-group, placebo controlled, international multicenter exploratory pilot study.

The objective of this study is to evaluate the effect of the 4 successive monthly subcutaneous administrations of 30 mg of gevokizumab (in part A) , as well as 60mg (in part B) of the protocol, versus placebo on the reduction of arterial wall…

A phase IV, randomized, open label, cross-over, intervention trial to investigate the effect of the switch of protease inhibitors to raltegravir on endothelial function, chronic inflammation, immune activation and HIV replication below 50 copies/ml

1. To assess the effect of the switch from protease inhibitors to raltegravir on endothelial function. 2. To assess the effect of the intervention mentioned above on markers of endothelial function; immune activation; chronic inflammation; and, on…

A randomized, open-label, parallel-group, multi-center study of adding edoxaban or clopidogrel to aspirin to maintain patency in subjects with peripheral arterial disease following femoropopliteal endovascular intervention-edoxaban in peripheral arterial disease (ePAD)

The aim of this study is to evaluate whether adding edoxaban to aspirin following femoropoplitealendovascular intervention will enable maintenance of vessel patency and prevent restenosisrelative to current treatment with clopidogrel and aspirin.

Randomized trial of Legflow® Paclitaxel eluting balloon (LPEB) with stentplacement vs. standard PTA with stentplacement for the treatment of intermediate (>5 cm and < 15 cm) and long (>15 cm) lesions of the superficial femoral artery (SFA). The RAPID trial.

The primary objective is to assess the difference in absence of binary restenosis rate of endovascular treatment of intermediate and long lesions of the superficial femoral artery with the Legflow® PEB and nitinol stent, when compared to uncoated…

Local delivery of CER-001 in advanced plaques
Proof-of-concept for apoA-1 as initiator of reverse cholesterol transport (LOCATION)

Primary1. To demonstrate that 89Zr-CER-001 penetrates into atherosclerotic plaques in patients by means of PET imaging. Secondary 2. To evaluate whether the amount of 89Zr-CER-001 penetrating the plaque corresponds to athero-lesion severity.3. To…

Effects of bosentan in a homogeneous population of SSc subjects with a predefined restriction of blood flow in the hands

The primary objectives are:- To demonstrate the relationship of blood flow in the hands and the extent of digital ulcera in patients with systemic scleroderma;- Evaluate the effect of bosentan on the blood flow in the hands from baseline to 12 weeks…

A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients whith Type 2 Diabetes

Primary objectivesEfficacyThe primary efficacy objective is to determine, as a superiority assessment, whether treatment with saxagliptin compared with placebo when added to current background therapy will result in a reduction in the composite…

Does the use of paclitaxel coated balloons inhibit restenosis in hemodialysis fistula? Results compared to conventional PTA balloons in a randomised trial.

Our objective is to evaluate the patency of paclitaxel coated balloons in hemodialysis patients presenting at the radiology department more than once a year with repetitive severe stenoses of their fistula, and compare the results with primary…

A phase II study of ARA 290 as therapeutic strategy in no-option critical limb ischemia patients.

A proof of concept study to test whether ARA 290 improves wound healing and reduces neuropathic pain in no-option patients with CLI