injury of an artery vascular complications
Conditions
Interventions
One group will undergo arteriotomy closure with the suture-based vascular
closure device, the other group will undergo arteriotomy closure with a
collagen-based MANTA device
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients undergoing elective transfemoral TAVI for severe aortic valve stenosis with any commercially-available transcatheter heart valve (THV) - Common femoral artery diameter > 5.0mm (14 - 22F compatible)
Exclusion criteria
Exclusion criteria: - Symptomatic leg ischaemia - Previous thromboendarterectomy or plastic patch of the common femoral artery - Previous implantation of a suture-based VCD less than 30 days before, or a plug-based VCD within 6 months - Unilateral or bilateral lower extremity amputation - Systemic infection or a local infection at or near the access site - Allergy to the components any of both devices (i.e. bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel) - Active bleeding or bleeding diathesis including thrombocytopenia (platelet count 1.8 at the time of the procedure - Patient unable to be adequately anti-coagulated for the procedure - Morbidly obese or cachectic (BMI >40 kg/m2 or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite of major vascular complications, and minor vascular complications according to VARC 2 at 30 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The individual components of the primary endpoint at 30 days and 1 year: major- and minor vascular complications defined bij VARC 2. - All-cause death including cardiac death, non-cardiac vascular death, non-cardiovascular death. - Major or life threatening bleedings according to VARC 2 - Need for transfusions for access site related bleeding/complications - Vascular closure device failure, defined as: placement of VCD not possible or failure of a closure device to achieve haemostasis at the arteriotomy site leading to alternative treatment (other than manual compression or adjunctive endovascular ballooning) - Intra-procedural complications at the femoral access site pre-sheath removal including bleeding or swelling around the large bore sheath that may indicate hematoma formation or pseudoaneurysm formation; or peri-procedural angiographic evidence of thrombus formation or significant injury in the aorta or iliac vessels associated with procedural large bore sheath placement and/or sub-optimal anticoagulation. - Time to haemostasis: elapsed time (minutes) between sheath removal and observed haemostasis - Procedure time - Time to ambulation (TTA) - Ambulation success - Technical success - Treatment success - Clinically relevant bleeding defined as BARC 2, 3 and 5 - Length of hospital stay - Pain and discomfort score | — |
Countries
Netherlands
Outcome results
None listed