Plug Arterial Closure System (PACS, 7F)
Summary
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 interventional coronary procedures using a standard 7F introducer sheath.
Description
Achieving hemostasis at the arterial puncture site after percutaneous cardiac catheterization is a potential cause of bleeding, hematomas, pseudoaneurysms, and various other vascular complications. Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression or the deployment of a vascular closure device. Manual compression is time consuming for the health-care provider, and painful for the patient. In addition, prolonged periods of immobilization and bed rest may be required. Vascular closure devices have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
The Ensure Medical Vascular Closure device (VCD) is intended for femoral artery puncture site closure in patients who have undergone coronary catheterizations using a standard 7F introducer sheath. The device is comprised of a bio-absorbable plug and a plug delivery system. The plug delivery system is designed to position the bio-absorbable plug to the extravascular surface of the femoral artery access site, facilitating a hemostasis response. The Ensure Medical VCD has been studied in a prior feasibility trial of 149 patients utilizing a 6F introducer sheath, which demonstrated that: (1) the device could be used to successfully obtain rapid hemostasis and early ambulation in patients undergoing catheterization procedures; and (2) the low incidence and relatively minor nature of the observed closure related complications suggests that the device is safe for its intended purpose.
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Angioplasty, Transluminal, Percutaneous Coronary
Intervention
Vascular access site closure (7F Ensure)
Location
Hospital Almater
Mexicali
Baja California
Mexico
21100
Status
Completed
Source
Ensure Medical
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00533156
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Angioplasty, Balloon
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.
Angioplasty, Transluminal, Percutaneous Coronary
Dilatation of an occluded coronary artery (or arteries) by means of a balloon catheter to restore myocardial blood supply.
Radiography, Interventional
Diagnostic and therapeutic procedures that are invasive or surgical in nature, and require the expertise of a specially trained radiologist. In general, they are more invasive than diagnostic imaging but less invasive than major surgery. They often involve catheterization, fluoroscopy, or computed tomography. Some examples include percutaneous transhepatic cholangiography, percutaneous transthoracic biopsy, balloon angioplasty, and arterial embolization.
Angioplasty, Laser
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).
Diskectomy, Percutaneous
Percutaneous excision of a herniated or displaced intervertebral disk by posterolateral approach, always remaining outside the spinal canal. Percutaneous nucleotomy was first described by Hijikata in Japan in 1975. In 1985 Onik introduced automated percutaneous nucleotomy which consists in percutaneous aspiration of the nucleus pulposus. It is carried out under local anesthesia, thus reducing the surgical insult and requiring brief hospitalization, often performed on an outpatient basis. It appears to be a well-tolerated alternative to surgical diskectomy and chymopapain nucleolysis.
Clinical Trials
Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device
The purpose of this study is to determine whether the Ensure Medical Vascular Closure Device is more effective than standard manual compression at sealing the puncture made in the femoral...
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.
Arterial Closure vs Direct Compression for Hemostasis After PCI-ACDC Trial
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 a...
Bypass Angioplasty Revascularization Investigation (BARI)
To assess the relative long-term safety and efficacy of percutaneous transluminal coronary angioplasty (PTCA) and coronary artery bypass graft (CABG) surgery in patients with multivessel d...
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
BACKGROUND: STAT, or the self-approximating transluminal access technique, has been previously described and involves the dissection of a submucosal tunnel for peritoneal or mediastinal access from th...
BACKGROUND: The use of access-site closure devices in interventional cardiology has expanded rapidly in the past several years. Initial reports indicated remarkable safety with these devices but there...
The Food and Drug Administration (FDA) is reclassifying the device type, standard percutaneous transluminal coronary angioplasty (PTCA) catheters, from class III (premarket approval) into class II (sp...
To retrospectively evaluate the safety and effectiveness of the EXOSEAL vascular closure device (VCD) for first or repeated closure after retrograde percutaneous femoral arterial access.
Percutaneous transluminal angioplasty for peripheral artery disease confers cardiorenal protection.
The effects of percutaneous transluminal angioplasty (PTA) on hemodynamic parameters are not established. We tested the hypothesis that PTA would achieve reductions in hemodynamic and target organ dam...
