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All Industry-driven Trials Investigator Initiated Trials

COMBINE-INTERVENE

The COMBINE-INTERVENE trial is a randomized international investigator-initiated trial to investigate whether a PCI revascularization strategy based on combined FFR and OCT assessment is superior to a PCI revascularization strategy based on FFR-alone in patients with MVD with any presentation. The COMBINE-INTERVENE trial is the first in line trial that will test focal percutaneous stenting for vulnerable plaque lesions independently from ischemia.

The COMBINE-INTERVENE trial is designed to enroll 1222 patients worldwide. The first patient was enrolled on 16 March 2022 in Romania. The trial geography includes about 50-60 centers in Europe, Asia-Pacific and North America. Patients will be followed for 2 years.

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ULTRACOLOR

The ULtrasound guided TRAnsfemoral access in COmplex Large bORe trial is an international multicenter RCT and will randomized patients with planned complex large bore PCI to either ultrasound guided or fluoroscopy guided transfemoral access.

The ULTRACOLOR trial is an international, multicenter, prospective, randomized clinical trial designed to enroll 542 patients in 10 centers in the Netherlands, Belgium and Germany.

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ULTRA-CTO

The ULTRA-CTO study is a prospective multicentre investigator-initiated trial designed to enroll subjects with an indication for percutaneous coronary intervention (PCI) of chronic total occluded (CTO) coronary artery and who have at least one intermediate (angiographically 30-90%) stenosis in a non-CTO vessel or major side branch of the CTO vessel with a diameter of at least 2 mm.

200 subjects will be enrolled in 2 centers in the Netherlands.

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CELEBRATE

A Phase 3 prospective, blinded, randomized, placebo controlled, international multicenter study to assess the clinical outcome at 30 days follow-up after administration of a single subcutaneous injection of zalunfiban versus placebo in STEMI subjects in the pre-hospital setting.

This multi-center study designed to enroll 2499 subjects will be conducted at up to 45 clinical sites (hospitals/ambulance services) in the Netherlands, Czech Republic, Hungary, France, Canada and the US.

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Dutch rivaroxaban CCS registry

The Dutch rivaroxaban CCS registry is a study which investigates the impact in terms of effectiveness and safety of the combination treatment of rivaroxaban 2.5 mg twice daily with aspirin on clinical outcomes and practices in a real-life Dutch patient population that are at high risk of ischemic events.

The multi-center study designed to enroll 1000 subjects will be conducted in the Netherlands.

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CEL-02

A Phase 2A open label study to assess the pharmacodynamic and pharmacokinetic properties of a single subcutaneous injection of RUC-4 in patients with a ST-elevation myocardial infarction presenting to the cardiac catheterization lab with planned primary coronary angioplasty.

This single-center study designed to enroll 24 evaluable subjects will be conducted at the St. Antonius hospital (Nieuwegein, The Netherlands).

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RFR-CABG

The RFR-CABG trial aims to compare RFR guided versus angiography guided CABG revascularization and to define the best cut-off value that predicts graft occlusion for RFR.

The RFR-CABG trial is an international prospective randomized multicenter superiority trial designed to enroll 500 patients in Belgium, Slovakia and Poland.

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DUTCH CANGRELOR REGISTRY

The Dutch Cangrelor Registry aims to investigate the efficacy and safety of cangrelor in the Netherlands.

The Dutch Cangrelor Registry is a multicenter non-interventional prospective registry aiming to include 250 patients in 8 centres in The Netherlands.

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ECTOPIA

The ECTOPIA trial aims to compare the efficacy of AAD (flecainide/verapamil and sotalol) and catheter ablation in reducing VPB burden after 3 months in patients with frequent symptomatic idiopathic VPB/VT.

The ECTOPIA trial is a national, multicenter, prospective, randomized clinical trial designed to enroll 180 patients in up to 6 centers in The Netherlands.

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DETECT AF

DETECT AF aims to examine the feasibility of screening persons of ≥65 years old for AAF and to validate the smartphone connected MED as an AAF screening instrument for application in transmural care in the Netherlands.

The DETECT AF project is a national prospective study designed to enroll 4000 patients in The Netherlands.

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