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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…

CINCOR* Trial III:Clinical Study of the CINCOR Contrast Removal Study for Patients with Chronic Kidney Disesease

The purpose of this clinical study is to provide confirmation of the clinical safety and performance of the CINCOR* System in removing contrast in patients at risk of developing CIN who are undergoing percutaneous coronary procedures.

Axetis Inert Coronary Stent System First in Man (FIM) Clinical Investigation

The objective is to assess the feasibility and safety of the Axetis Inert Stent for treatment of patients with de novo coronary artery stenosis in native vessels.

A multicenter, prospective randomized study to compare vascular healing after deployment of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo Bio-Engineered Sirolimus Eluting Stent) versus the Everolimus Eluting Stent in patients with Acute Coronary Syndrome by means of Optical Coherence Tomography

See also page 19 (section 6) of the protocol:6. Study ObjectiveIt is the objective of this study to assess vascular healing by Optical Coherence Tomography (OCT) analysis after deployment of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo…

PIONEER Trial, A Prospective, Multicentre, Single arm, Non-Inferiority Clinical Trial to evaluate safety of Drug Eluting PTCA Balloons and CoCr coronary Stents mounted on a Drug Eluting Balloon

To evaluate the safety and performance of the Paclitaxel Eluting Balloon Balloon mounted with a Cobalt Chromium stent (DEBS) and Paclitaxel Eluting Balloon (DEB) in patients with de novo coronary artery disease.

CLINICAL INVESTIGATION OF A DES (MISTENT* SYSTEM) WITH SIROLIMUS AND A BIOABSORBABLE POLYMER FOR THE TREATMENT OF PATIENTS WITH DE NOVO LESIONS IN NATIVE CORONARY ARTERIES

The primary objective of this study is to demonstrate whether the MiStent Drug Eluting Coronary Stent System can safely and effectively improve coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo…

The effect of helium inhalation on the coronary circulation and vessel diameter

The primary objective is to investigate whether helium influences coronary artery circulation in humans undergoing elective percutaneous coronary interventions (PCI).

Maintenance of platelet inhiBition with cangreloR after dIscontinuation of
thienopyriDines in patients undergoing surGEry: The BRIDGE trial

The primary hypotheses in this study is that a cangrelor infusion will maintain target levels of platelet inhibition (> 60% inhibition) after discontinuation of a thienopyridine (clopidogrel or ticlopidine) in patients waiting for surgery.

A RANDOMIZED, PARTIALLY-BLINDED, MULTI-CENTER, ACTIVE-CONTROLLED, DOSE
RANGING STUDY ASSESSING THE SAFETY, EFFICACY, AND PHARMACODYNAMICS OF THE
REG1 ANTICOAGULATION SYSTEM COMPARED TO UNFRACTIONATED HEPARIN OR LOW
MOLECULAR HEPARIN IN SUBJECTS WITH ACUTE CORONARY SYNDROME

To evaluate the safety and efficacy of the REG1 Anticoagulation System in Acute Coronary Syndrome patients undergoing cardiac catheterization by determination of the clinically acceptable dose range of RB007, which can be used to reliably reverse…

Phase IIb multi-center, double-blind, randomized, parallel group, placebo-controlled clinical trial for the assessment of coronary plaque changes with RVX000222, as determined by intravascular ultrasound

Primary ObjectiveTo evaluate the effect of RVX000222 on the change in burden of coronary atherosclerosis, as measured by percent atheroma volume (PAV), in patients with coronary artery disease and a low level of HDL-C requiring angiography for a…

Prospective, multi-center, randomized, heparin-controlled dose-finding trial to evaluate the efficacy and safety of rivaroxaban, a direct factor Xa inhibitor, on the background of standard dual antiplatelet therapy to support elective percutaneous coronary intervention (X-Plorer).

The aim of this study is to assess whether rivaroxaban, as compared to UFH, on the background of standard dual antiplatelet therapy (DAPT), can effectively suppress thrombosis, and related adverse ischemic events, upon balloon inflation and stent…

Canyon-I-Pilot Trial a dose-ranging study of bolus-only Desirudin in patients undergoing PCI

The aim of this study is to find out if a percutaneous angioplasty can be carried out safely in patients who received a therapeutic dose of Desirudin (Revasc®) before the operation.

A Prospective, Randomized Study to Evaluate the Safety and Effectiveness of
an AbluMinal Sirolimus CoatED Bio-Engineered StEnt (Combo Bio-
Engineered Sirolimus Eluting Stent) Compared with a TAXUS® Liberté® Stent
Control Arm for Treatment of Stenotic Lesions in Native Coronary Arteries

The primary objective of this clinical trial is to demonstrate the safety and effectiveness of the Combo Bio-engineered Sirolimus Eluting Stent (Combo Stent) compared to the commercially available TAXUS® Liberté® Paclitaxel-Eluting Stent (DES) in…

Shockwave treatment for advanced angina in Maastricht (SWAAM). A double blind randomised study.

Goal of the project is to implement the shockwave therapy for no-option CAD patients and to evaluate its potential benefit on regional myocardial perfusion, on regional myocardial function and on the potential improvement in symptoms and quality of…

Can HDL Infusions Significantly Quicken Atherosclerosis Regression?
A phase II, Multi-center, double-blind, ascending dose, placebo-controlled, dose-finding trial of CER-001 or placebo in subjects with acute coronary syndrome.

To assess the impact of six IV infusions of 3, 6, or 12 mg/kg of CER-001 or placebo, given at weekly intervals, on atherosclerotic plaque volume, as measured by coronary IVUS.

Ultrasound contrast agents to facilitate sonothrombolysis in patients with acute myocardial infarction

Primary objective: Can application of diagnostic ultrasound and microbubbles enhance epicardial coronary recanalization with a lower and safer dose of a thrombolytic agent such as alteplase 50mg when combined with normal care consisting of prasugrel…

Does helium protect the heart against ischaemia-reperfusion damage in patients with acute myocardial infarction?

To investigate whether the inhalation of helium during rpimary PCI can reduces the size of myocardial infarction.

A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and its Effects on Markers of Intravascular Inflammation in Subjects with Coronary Artery Disease

The primary objectives of the study are to assess the safety and tolerability of E5555 in subjects with coronary artery disease (CAD) (Revised per Amendment 01).The secondary objectives are to determine the effect of E5555 on (a) the incidence of…

A Randomised, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and its Effects on Clinical Events and Biomarkers in Patients with Non-ST-Segment Elevation Acute Coronary Syndrome

The primary objectives of the study are to investigate the safety and tolerability of E5555 at three dose levels in patients admitted to hospital with symptoms of Acute Coronary Syndrome (ACS). This will be assessed for a period of up to 16 weeks (…