DRKS00000802.

Trial name or title	VCD trial
Methods	Study design : prospective, randomised clinical trial Country : Germany Setting : hospital Number of centres : multi‐centre
Participants	Inclusion criteria Patients 18 years of age or older Undergoing diagnostic angiography or coronary intervention with a 5 Fr or 6 Fr introducer sheath via femoral artery puncture Exclusion criteria Uncontrolled blood pressure > 180/110 mmHg Previous vascular surgery or femoral bypass surgery Previous femoral or iliac vascular intervention Former femoral vascular closure with internal closure system (e.g. AngioSeal, CoStar) Heavily calcified or atheromatous modified femoral artery
Interventions	Intervention 1 : ExoSeal Intervention 2 : Safeguard Intervention 3: manual compression
Outcomes	Primary Combined endpoint of complications after puncture of the femoral artery (haematoma ≥ 5 cm, aneurysm spurium, bleeding with haemoglobin decrease ≥ 2 mg/dL, transfusion requirement, retroperitoneal haemorrhage, pressure ulcer ≥ grade 2, ischaemia of the ipsilateral lower extremity, nerve injury within 48 hours, after 7 days and 31 days Secondary Haematoma < 5 cm Bleeding with haemoglobin drop < 2 mg/dL Abrasion of the skin Pressure ulcer grade 1 Prolonged tourniquet time Prolonged hospitalisation Fever within 24 hours after surgery Local infection of the puncture Pain User satisfaction
Starting date	May 2011
Contact information	stefan.köberich at uniklinik‐freiburg.de marc.kollum at hbh‐kliniken.de
Notes