To show if a combination therapy of rivaroxaban plus Aspirin® is more efficient (superiority testing) as rivaroxaban alone in the prevention of early venous stent thrombosis in patients suffering from post-thrombotic syndrome in the first 6 months following endovascular therapy.
To demonstrate tolerability of combination therapy of Aspirin® plus rivaroxaban in long-term treatment.

Observational study of standard of care anticoagulation (rivarobaban dosis defined in the clinical routine).

Venous Thromboses

Stent Stenosis

Aspirin® cardio (CH) or Aspirin® protect (DE, AT) Film coated tablets Acetylsalicylic acid 100 mg Once daily oral intake for 6 months

Aspirin 100mg

University Hospital Zurich

Aspirin® Plus Rivaroxaban Versus Rivaroxaban Alone for the Prevention of Venous Stent Thrombosis in Patients With PTS

Aspirin® Plus Rivaroxaban Versus Rivaroxaban Alone for the Prevention of Venous Stent Thrombosis in Patients With Post-thrombotic Syndrome a Multi-center, International, Randomized, Open Label, Controlled Trial

The primary patency rate is defined as the percentage of patients with primary treatment success after 6 months (=Visit 3), i.e. without the occurrence of either i) occlusion of at least a part of the stent segment or ii.) a re-intervention to maintain patency of the treated segment.

The primary patency rate is defined as the percentage of patients with primary treatment success after 3 months (=Visit 2), i.e. without the occurrence of either i) occlusion of at least a part of the stent segment or ii.) a re-intervention to maintain patency of the treated segment.

Secondary patency rate is defined as the percentage of patients with primary treatment success and without the occurrence of occlusion of at least a part of the stent segment, irrespective of any re-intervention

Primary sustained clinical success, defined as the absence of post-thrombotic syndrome (Villalta score 0-4 points) without the need for repeated intervention assessed at the latest routine follow-up visit (at the latest available follow-up).

Difference between treatment groups in the incidence of patients with open stents but >50% residual stenosis according Duplex criteria

Difference of limb circumference of the affected leg in comparison to the contralateral leg at 3 and 6 months (= Visit 2 & 3), respectively, compared to baseline (for patients with only one affected leg)

Quality of life using the CIVIQ-20 (chronic venous insufficiency quality of life questionnaire) at 3 and 6 months (= Visit 2 & 3), respectively, compared to baseline.
Value range: 20-100 points; Higher scores mean worse outcome

Change in Villalta score with and without "ulcus cruris assessment" for the affected leg from baseline to 3 and 6 months (= Visit 2 & 3), respectively.
Value range: 0-48 points; Higher scores mean worse outcome

Revised venous clinical severity score (rVCSS) for the affected leg from baseline to 3 and 6 months (= Visit 2 & 3), respectively.
Value range: 0-30 points; Higher scores mean worse outcome

University of Zurich

a multi-center, international, randomized, open label, controlled trial

Patient diagnosed with ST elevation myocardial infarction will undergo bioresorbable stent deployment in culprit lesion.

STEMI

Cardiovascular Disease

Bioresorbable Scaffold

Once baseline angiography is performed and all eligibility criteria are met, the patient is included in the study. The target lesion should be crossed with a standard coronary guidewire. Next, the NIRS/IVUS and OCT probe is inserted and a pullback is being performed to evaluate the lesion and vessel morphology. The predilatation with 1:1 non-compliant or semi-compliant balloon is mandatory. Thereafter the scaffold should be inserted and position across the target lesion. Lesions up to 14 mm should be covered with the 18 mm device, for lesions of 15-20 mm a 24 mm device should be used. The scaffold will be deployed with intent to achieve the inner diameter to the reference vessel ration of 1:1 using a single inflation. Post-dilatation using a non-compliant balloon should be performed to achieve complete scaffold apposition and reduce the residual angiographic stenosis below 20%. The final NIRS/IVUS and OCT of the target vessel should be performed.

PCI with Phantom Bioresorbable Scaffold

1st Department of Cardiology, Medical University of Warsaw

Vascular Healing After Implantation of FANTOM Bioresorbable Scaffold in STEMI: A FANTOM STEMI Study

Vascular Healing Pattern, Vasoreactivity, and Quality of Life in Patients With ST Segment Elevation Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention With Sirolimus Eluting FANTOM Bioresorbable Vascular Scaffold With Long Term Clinical, Near Infrared Spectroscopy and Optical Coherence Tomography Follow-up: A FANTOM STEMI Pilot Study

acetylsalicylic acid/edema

Aspirin® Plus Rivaroxaban Versus Rivaroxaban Alone for the Prevention of Venous Stent Thrombosis in Patients With PTS

Vascular Healing After Implantation of FANTOM Bioresorbable Scaffold in STEMI: A FANTOM STEMI Study

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