The applied selection criteria were equal for intact and re-do groins. A preprocedural CT scan was performed from each patient to plan the procedure including the access strategy. Criteria evaluated before choosing percutaneous access were: calcification, diameter, and stenosis of the femoral and external iliac artery. A percutaneous access was chosen if the access vessel had a diameter >6 mm and was free from anterior calcification. The common femoral artery was the preferential access site, but in case of a high bifurcation the superficial femoral artery was used. The access technique was chosen by the senior operating physician at each institution. All physicians were experienced in the use of ProGlide (Abbott Vascular, Santa Clara, Calif) and Angioseal (St Jude Medical, Minnetonka, Minnesota) devices.
Angioseal
Manufactured by Abbott
Sourced in United States
Angioseal is a vascular closure device manufactured by Abbott. It is designed to facilitate the closure of femoral artery puncture sites following percutaneous endovascular procedures.
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7 protocols using angioseal
1
Percutaneous Access Criteria Evaluation
2
Porcine Model of Acute Myocardial Infarction
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All animal studies were approved by the local Experimental Animal Care Committee of University of Kaposvar, Hungary where the experiments were performed (EC 246/002/SOM2006, MAB-28-2005). The experiments conform to the “Position of the American Heart Association on Research.”
Closed-chest, acute reperfused MI was induced in 39 female domestic pigs (23 ± 3 kg) by percutaneous catheter-based balloon occlusion of the left anterior descending coronary artery (LAD), as described previously (Gyongyosi et al., 2011 (link)). Briefly, after direct puncture of the right femoral artery and administration of 200 IU/kg of heparin, a 90-min percutaneous balloon (3.0 mm in diameter × 15 mm long, Maverick, Boston Scientific Corp., Natick, MA, USA) occlusion (5 atm) of the mid LAD, beyond the origin of the second major diagonal branch was performed. The complete occlusion of the artery distal to the balloon was confirmed by angiography. After a 90-min LAD occlusion, the balloon was deflated slowly to allow reperfusion. The puncture site was then closed with Angioseal (St. Jude Medical, St. Paul, MN, USA), and the pigs were allowed to recover.
One-week (8 ± 2 days) post-MI, the pigs were randomized to receive either IC infusion or 3D NOGA-guided percutaneous intramyocardial injections of the GFP-Luc-MSC. The study design with different follow-ups (FUPs) is shown in Figure1 .
Closed-chest, acute reperfused MI was induced in 39 female domestic pigs (23 ± 3 kg) by percutaneous catheter-based balloon occlusion of the left anterior descending coronary artery (LAD), as described previously (Gyongyosi et al., 2011 (link)). Briefly, after direct puncture of the right femoral artery and administration of 200 IU/kg of heparin, a 90-min percutaneous balloon (3.0 mm in diameter × 15 mm long, Maverick, Boston Scientific Corp., Natick, MA, USA) occlusion (5 atm) of the mid LAD, beyond the origin of the second major diagonal branch was performed. The complete occlusion of the artery distal to the balloon was confirmed by angiography. After a 90-min LAD occlusion, the balloon was deflated slowly to allow reperfusion. The puncture site was then closed with Angioseal (St. Jude Medical, St. Paul, MN, USA), and the pigs were allowed to recover.
One-week (8 ± 2 days) post-MI, the pigs were randomized to receive either IC infusion or 3D NOGA-guided percutaneous intramyocardial injections of the GFP-Luc-MSC. The study design with different follow-ups (FUPs) is shown in Figure
3
Vascular Closure Device Deployment
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At the end of the procedure, the operator decided to use either a vascular closure device or manual compression for femoral artery puncture. If a VCD was chosen, an Angio-Seal™ device (St. Jude Medical, Minnetonka, MN, USA) that consists of an intra-arterially deployed polymer anchor, a collagen sponge positioned on the outer artery wall, and a self-tightening suture was used. The whole system is bioabsorbed within 90 days. All patients were followed-up by an experienced emergency physician. Hb-relevant bleeding was defined as a haemoglobin drop of more than 3 g/dl within the first 24 hours following coronary angiography and exclusion of other obvious causes or clinical bleeding signs.
4
Coronary Angiographic Procedures Standardization
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CCA was performed after CTA/CTP using the routine clinical protocol and angiographic projections were standardised [17 (link)]. The femoral artery was punctured after local anesthesia with approx. 150–200 mg lidocaine (Lidoject, Hexal AG, Holzkirchen, Germany). A nonionic, iodinated contrast agent (iobitridol, Xenetix 350, Guerbet, Villepinte, France) was used. Fractional flow reserve (FFR) was measured in a total of 8 patients. Adenosine (140 μg/kg/min; Adenosin Life Medical, Carinopharm GmbH, Gronau/Leine, Germany) was infused intra-arterially via the cardiac catheter for 3 to 5 min, at the cardiologist’s discretion to identify culprit lesions [18 (link)]. After the examination, a suture closure device was used in 66 cases (AngioSeal, St. Jude Medical, Minnesota, USA; Starclose and Perclose, Abbott Laboratories, Illinois, USA), and 4–6 h of bed rest were ordered. The compression bandage was removed after 2–3 h. In the 22 cases where manual compression was used, 12 h of bed rest were required, and the compression bandage was removed after 6 h.
5
Elective PCI Complications and Closure Devices
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Definitions used for this study included the following:
Elective PCI: Any coronary revascularization performed on a stable patient presenting to the institution for a planned or an ad hoc PCI.
Suboptimal angiographic result: A residual stenosis of >40% after angioplasty, as estimated by visual assessment.
Vascular site access concerns: Any vascular site complications, such as bleeding that required transfusion, retroperitoneal hemorrhage, arteriovenous fistula, pseudoaneurysm, thrombosis, arterial dissection, minor bleeding, or hematomas.
Femoral closure device: Vascular closure devices to achieve hemostasis, such as Mynx (AccessClosure, Santa Clara, CA); Angioseal (St. Jude Medical, Minnetonka, MN); or Perclose (Perclose, Redwood City, CA).
6
Periprocedural Bleeding Events in Arterial Punctures
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All periprocedural bleeding events associated with arterial puncture site occurring on admission were recorded. A TR band (Terumo Corporation, Tokyo, Japan) for hemostasis was applied in patients who underwent puncture of the radial artery, whereas manual compression, Angio‐Seal (St. Jude Medical, Inc, Saint Paul, MN), or Perclose ProGlide (Abbott Vascular Co, Abbott Park, IL), was used for vascular closure in patients who underwent puncture of the femoral artery. We defined periprocedural bleeding as a composite of the International Society on Thrombosis and Hemostasis major bleeding,18 access site hematoma required additional manual compression, and hematoma related with arteriovenous shunt or pseudoaneurysm.
7
Endovascular Paclitaxel-Eluting Stent Protocol
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Endovascular procedures have already been described. 6 Briefly, the self expandable paclitaxel eluting stent (Zilver PTX, Cook Medical, Bloomington, IN, USA) was the only stent implanted (5e7 mm diameter). The maximum available length of the stent was 120 mm. Lesions were treated with as few stents as possible. Stent diameter was chosen to be the size of the vessel diameter, and remodeling of the stent was achieved through the use of a balloon 1 mm smaller than the stent. When several stents were necessary, there was a 1 cm overlap between stent edges. Concomitant procedures were performed according to the surgeon's preference. Groin closure was usually accomplished by manual compression and, for day case procedures, an arterial closure device was used (Angioseal, St Jude Medical, Boulogne-Billancort, France).
A prophylactic dose of low molecular weight heparin was given during hospitalization to prevent venous thromboembolic events. Post-operatively, patients were prescribed aspirin (75e160 mg/day) and clopidogrel (75 mg/day) for 6 months followed by clopidogrel alone. 9 When patients were already taking oral anticoagulants, aspirin was the only antiplatelet agent added.
A prophylactic dose of low molecular weight heparin was given during hospitalization to prevent venous thromboembolic events. Post-operatively, patients were prescribed aspirin (75e160 mg/day) and clopidogrel (75 mg/day) for 6 months followed by clopidogrel alone. 9 When patients were already taking oral anticoagulants, aspirin was the only antiplatelet agent added.
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