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Arterial Closure vs Direct Compression for Hemostasis After PCI-ACDC Trial

2014-08-27 03:47:12 | BioPortfolio

Summary

Hemostasis at the arterial puncture site after percutaneous coronary interventions is achieved by either placement of a puncture closure device or by delaying sheath removal for hours to allow normalization of heparin induced anticoagulation. Both of these methods are far from ideal. Delayed sheath removal poses a risk of recurrent bleeding, hematoma formation and results in decreased patient mobility while the safety of closure devices has been called into question by several recent reports. Due to the lack of definitive data, the arterial access site management varies considerably between physicians and among institutions. The proposed study will evaluate the safety and efficacy of arterial closure devices to achieve hemostasis compared with immediate sheath removal after protamine administration followed by direct compression after percutaneous coronary intervention procedures.

Description

Percutaneous coronary intervention (PCI) is the most common procedure performed for obstructive coronary artery disease with more than one million procedures performed annually in United States alone1. Despite major advances in technology and operative expertise, the optimum management of arterial access site after PCI procedures remains unclear.

The conventional practice of arterial access site management involves delaying of sheath removal for several hours to allow normalization of heparin induced anticoagulation. This delayed sheath removal poses a risk of recurrent bleeding and hematoma formation. Furthermore, delayed sheath removal results in decreased patient mobility, increased patient discomfort and requires frequent monitoring with an impact on nursing resources. The risks associated with delayed sheath removal may be further increased by concomitant administration of potent anti platelet therapy now routinely used in patients undergoing PCI2.

Arterial puncture closure devices (APCD) were developed to obtain immediate arterial access site hemostasis after closed vascular procedures with an aim towards early patient mobilization. Although the efficacy of APCD have been documented in several small studies but limited information is available regarding their safety in diverse patient populations. A recent meta analysis has shown increased vascular complication rate associated with the use of these devices bringing the safety of their routine use into question3.

Due to lack of definitive data, the arterial access site management varies considerably between physicians and among institutions. APCD are routinely used by some centers4 while others continue to delay arterial sheath removal for several hours after the procedure5.

Immediate sheath removal followed by direct compression though routinely practiced after coronary angiographic procedures is not used after PCI procedures due to the intra procedural administration of heparin resulting in prolonged anticoagulation. Reversal of heparin with protamine may allow immediate sheath removal resulting in early patient ambulation and decreased access site vascular complications. The safety and efficacy of intravenous protamine administration for reversal of heparin is well established by its routine use in cardiovascular surgery for several decades6 and recent reports showing safety and efficacy of this method for early sheath removal after PCI procedures7-9.

The proposed study is designed to evaluate the safety and efficacy of immediate sheath removal followed by direct compression as compared to the use of APCD to achieve hemostasis after PCI.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Conditions

Coronary Angioplasty

Intervention

Closure devices

Location

St. Michael's Hospital
Toronto
Ontario
Canada
M5B1W8

Status

Recruiting

Source

St. Michael's Hospital, Toronto

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:47:12-0400

Clinical Trials [1965 Associated Clinical Trials listed on BioPortfolio]

Arterial Closure Device Comparison Trial II – ACDC Trial II

PCI (coronary angioplasty) is a procedure performed through a catheter to open up blockages in the coronary arteries using balloons and stents for the treatment of angina or myocardial inf...

Plug Arterial Closure System (PACS, 7F)

The purpose of this study is to assess the safety and feasibility of the 7F Ensure Medical Vascular Closure Devices to facilitate hemostasis in patients undergoing diagnostic or interventi...

Emory Angioplasty Versus Surgery Trial (EAST)

To compare the efficacy of coronary artery bypass graft (CABG) surgery with percutaneous transluminal coronary angioplasty (PTCA) in patients with multiple vessel coronary heart disease.

The Paclitaxel-Eluting Percutaneous Coronary Angioplasty (PTCA)-Balloon Catheter for the Treatment of Coronary Bifurcations

The intention of this trial is to assess the safety and efficacy of Drug Eluting Balloon (DEB) application (SeQuent Please) to the side branch in percutaneous coronary intervention (PCI) o...

Patient Comfort With Vascular Closure

The purpose of this research study is to collect information on the amount of discomfort patients experience with one of two different vascular blood vessel closure devices, the MynxM5 Vas...

PubMed Articles [4713 Associated PubMed Articles listed on BioPortfolio]

Network meta-analysis of studies comparing closure devices for femoral access after percutaneous coronary intervention.

Different devices have been released for closure of femoral vascular access after coronary angiography or percutaneous coronary intervention, whereas evidence about their efficacy and safety when comp...

Percutaneous coronary intervention for treating de-novo lesions in small coronary vessels: initial experience with the Essential paclitaxel-coated balloon.

Paclitaxel-coated balloon (PCB) coronary angioplasty is an alternative treatment for de-novo coronary lesions in small vessels. This study with the new Essential PCB aimed to evaluate early and mid-te...

Coronary venous angioplasty to facilitate trans-venous left ventricular lead placement: A single-center 13-year experience.

Barriers to successful left ventricular lead placement within the coronary venous anatomy may include focal stenoses, thromboses, phrenic nerve stimulation, vessel tortuosity, small vessel caliber, no...

Robotic-Assisted Percutaneous Coronary Intervention of a Saphenous Vein Graft Stenosis using a FilterWire EZ Embolic Protection.

Robotic-assisted coronary angioplasty has been utilized to decrease radiation exposure to cardiologists, and to diminish risk of orthopedic and ergonomic injuries caused by wearing heavy lead during l...

Historical Milestones in the Management of Stable Coronary Artery Disease over the Last Half Century.

Coronary revascularization for coronary artery disease dates to the introduction of coronary bypass surgery by Favaloro in 1967 and coronary angioplasty by Gruentzig in 1977 and first published in 196...

Medical and Biotech [MESH] Definitions

A family of percutaneous techniques that are used to manage CORONARY OCCLUSION, including standard balloon angioplasty (PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY), the placement of intracoronary STENTS, and atheroablative technologies (e.g., ATHERECTOMY; ENDARTERECTOMY; THROMBECTOMY; PERCUTANEOUS TRANSLUMINAL LASER ANGIOPLASTY). PTCA was the dominant form of PCI, before the widespread use of stenting.

Use of a balloon catheter for dilatation of an occluded artery. It is used in treatment of arterial occlusive diseases, including renal artery stenosis and arterial occlusions in the leg. For the specific technique of balloon dilatation in coronary arteries, ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY is available.

Dilatation of an occluded coronary artery (or arteries) by means of a balloon catheter to restore myocardial blood supply.

Dilation of an occluded coronary artery (or arteries) by means of a balloon catheter to restore myocardial blood supply.

A technique utilizing a laser coupled to a catheter which is used in the dilatation of occluded blood vessels. This includes laser thermal angioplasty where the laser energy heats up a metal tip, and direct laser angioplasty where the laser energy directly ablates the occlusion. One form of the latter approach uses an EXCIMER LASER which creates microscopically precise cuts without thermal injury. When laser angioplasty is performed in combination with balloon angioplasty it is called laser-assisted balloon angioplasty (ANGIOPLASTY, BALLOON, LASER-ASSISTED).

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