Abbott Vascular

A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold (Absorb™ BVS) System in Chinese Population ~ ABSORB CHINA RCT
To evaluate the safety and efficacy of the Absorb BVS System compared to the XIENCE V EECSS in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.
Status: Recruiting Start Date: July 2013 Completion Date: July 2019
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study
Abbott Vascular (AV) obtained marketing approval for the XIENCE PRIME Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS) in China from the China Food and Drug Administration (CFDA) on August 10th, 2011. This prospective, observational, open-label, multi-center, single-arm, post-approval [more...]  study is designed to evaluate the continued safety and effectiveness of the XIENCE PRIME EECSS in a cohort of real-world patients receiving the XIENCE PRIME EECSS during commercial use in real-world settings in China. This study has no primary outcome measure. All observations are of equal weight.
Status: Recruiting Start Date: July 2013 Completion Date: July 2019
AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population
Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter, Japanese Clinical Trial to evaluate the safety and effectiveness of Absorb™ BVS (AVJ-301) in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions in [more...]  Japanese population by comparing to approved metallic drug eluting stent.
Status: Recruiting Start Date: April 2013 Completion Date: May 2019
ABSORB FIRST Registry
ABSORB FIRST is a registry designed to: - Provide ongoing post-market surveillance for documentation of safety and clinical outcomes of the Absorb BVS (Bioresorbable Vascular Scaffold) System in daily PCI [more...]  practice per Instructions for Use (IFU, on-label use). - Collect additional information (e.g. acute success) to evaluate handling and implantation of Absorb BVS by physicians under a wide range of commercial use conditions and following routine clinical practice.
Status: Recruiting Start Date: January 2012 Completion Date: November 2018
THE ABSORB III RANDOMIZED CONTROLLED TRIAL (RCT)
A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de novo Native Coronary Artery Lesions.
Status: Recruiting Start Date: December 2012 Completion Date: March 2018
XIENCE PRIME Everolimus Eluting Coronary Stent Post Marketing Surveillance (PMS) in Japan
The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE Prime) as well as to collect information on evaluation of the efficacy and safety for reevaluation.
Status: Recruiting Start Date: November 2012 Completion Date: April 2018
Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy
The objective of the CANOPY trial is to assess the continued safety and effectiveness of the RX Acculink Carotid Stent System under commercial use in subjects at standard risk for adverse events from Carotid Endarterectomy (CEA) enrolled by physicians with a range of [more...]  carotid stenting experience.
Status: Recruiting Start Date: October 2011 Completion Date: December 2016
Absolute Pro® MOMENTUM™
To evaluate the safety and effectiveness of the Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL Peripheral Self-Expanding Stent System for the treatment of subjects with atherosclerotic de novo or restenotic lesions in the native superficial [more...]  femoral artery (SFA) and/or the native proximal popliteal artery (PPA). CAUTION: Absolute Pro® Peripheral Self-Expanding Stent System and the Absolute Pro® LL Peripheral Self-Expanding Stent Systems are investigational devices. Limited by Federal (U.S.) law to investigational use only.
Status: Recruiting Start Date: October 2011 Completion Date: January 2017
ABSORB II Randomized Controlled Trial
Prospective, randomized (2:1), active control, single blinded, parallel two-arm, multi-center clinical investigation using Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System (ABSORB BVS); compared to Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System (XIENCE)
Status: Recruiting Start Date: November 2011 Completion Date: July 2016
EXCEL Clinical Trial
To establish the safety and efficacy of the XIENCE PRIME or XIENCE V or XIENCE Xpedition or XIENCE PRO Everolimus Eluting Coronary Stent System (EECSS) in subjects with unprotected left main coronary artery disease by comparing to coronary artery bypass graft surgery. [more...]  Notes: 1. XIENCE Xpedition and XIENCE PRO are newly added to the XIENCE Family Stent System. 2. XIENCE PRO will be used only outside of the United States [OUS].
Status: Recruiting Start Date: September 2010 Completion Date: December 2021
ABSORB EXTEND Clinical Investigation
The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System ABSORB BVS is currently in development at Abbott Vascular.
Status: Recruiting Start Date: January 2010 Completion Date: September 2016
ESPRIT I: A Clinical Evaluation of the Abbott Vascular ESPRIT BVS (Bioresorbable Vascular Scaffold) System
The purpose of the ESPRIT I Clinical Investigation is to evaluate the safety and performance of the ESPRIT BVS in subjects with symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.
Status: Active, not recruiting Start Date: November 2011 Completion Date: August 2015
EXPERT CTO: Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions
A prospective, multi-center, single-arm study to establish the safety and effectiveness of the XIENCE V® Everolimus Eluting Coronary Stent, XIENCE nano™ Everolimus Eluting Coronary Stent, XIENCE PRIME™ LL Everolimus Eluting Coronary Stent, HT PROGRESS and HT PILOT Coronary Guide [more...]  Wires, and MINI-TREK Coronary Dilatation Catheter in patients undergoing elective percutaneous revascularization of native chronic total coronary occlusions
Status: Active, not recruiting Start Date: September 2011 Completion Date: February 2018
Trial to Evaluate the Safety & Efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery
To determine the safety and efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in subjects with atherosclerotic de novo or restenotic lesions in the native common iliac artery and/or native external iliac artery.
Status: Active, not recruiting Start Date: March 2009 Completion Date: January 2014
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study
This is a prospective, observational, single-arm, open-label, multicenter, postapproval registry study in China. The purpose of this study is to: - Evaluate the continued safety and effectiveness of the XIENCE V EECSS in a cohort of [more...]  real-world patients receiving the XIENCE V EECSS during commercial use - Evaluate patient compliance to dual antiplatelet therapy (DAPT)
Status: Active, not recruiting Start Date: November 2010 Completion Date: January 2017
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)
This is a prospective, randomized, active-controlled, open label, parallel two-arm, multi-center, post-approval study descriptively comparing the XIENCE V EECSS to the CYPHER SELECT PLUS Sirolimus-Eluting Coronary Stent System (SECSS) ("CYPHER SELECT PLUS") during commercial use in China.
Status: Active, not recruiting Start Date: August 2010 Completion Date: February 2014
XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA Long Term Follow-up Cohort)
XIENCE V USA is a prospective, multi-center, multi-cohort post-approval study. The objectives of this study are - To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real [more...]  world settings, and - To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT) initiative. This initiative is designed to evaluate the composite of all death, myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and that have been treated with drug eluting stents (DES) and extended dual antiplatelet therapy.
Status: Active, not recruiting Start Date: July 2008 Completion Date: December 2014
A Clinical Evaluation of the AVJ-09-385 Small Vessel Everolimus Eluting Coronary Stent System in Japanese Population
The purpose of this study is to evaluate the safety and effectiveness of the AVJ-09-385 Small Vessel Everolimus Eluting Coronary Stent System (2.25 mm diameter stent) in treatment of subjects with ischemic heart disease caused by de novo lesions.
Status: Active, not recruiting Start Date: April 2010 Completion Date: August 2016
XIENCE V/PROMUS Everolimus-Eluting Stent System Post-marketing Surveillance Protocol for Japan
The objectives of this post-marketing surveillance, conducted in Japan, is to know the frequency, type and degree of device malfunction, to assure the safety of the medical device, and to collect information on evaluation of the efficacy and safety.
Status: Active, not recruiting Start Date: March 2010 Completion Date: August 2016
SPIRIT PRIME Clinical Trial
To evaluate the safety and effectiveness of the XIENCE PRIME and XIENCE PRIME Long Lesion (LL) Everolimus Eluting Coronary Stent System (EECSS) in improving coronary luminal diameter in subjects with symptomatic heart disease due to a maximum of two de novo native coronary [more...]  artery lesions, each in a different epicardial vessel.
Status: Active, not recruiting Start Date: June 2009 Completion Date: April 2016
ABSORB Clinical Investigation, Cohort B
The purpose of this study is to assess the safety and performance of the BVS Everolimus Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in two different major epicardial vessels. [more...]  Currently in development at Abbott Vascular. Not available for sale in the United States.
Status: Active, not recruiting Start Date: March 2009 Completion Date: December 2014
Trial to Evaluate the Safety & Efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery.
To determine the safety and efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System in subjects with atherosclerotic de novo or restenotic lesions in the native common iliac artery and/or native external iliac artery.
Status: Active, not recruiting Start Date: March 2009 Completion Date: June 2013
SPIRIT Small Vessel Registry
To evaluate the safety and effectiveness of the 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in improving coronary luminal diameter in subjects with ischemic heart disease due to a maximum of two de novo native coronary artery lesions [more...]  in small vessels, each in a different epicardial vessel.
Status: Active, not recruiting Start Date: October 2008 Completion Date: October 2014
EXecutive Registry: Evaluating XIENCE V® in a Multi Vessel Disease
The purpose of this two part study is the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of the specific setting of patients with Multi-Vessel Coronary Artery Disease (MVD).
Status: Completed Start Date: September 2007 Completion Date: June 2011
EXCEL Clinical Trial (Universal Registry)
The purpose of the Universal Registry is to assess the proportion and reasons for which subjects with angiographically significant ULMCA disease requiring revascularization during the time course of this study are not randomized; to compare the baseline characteristics of [more...]  subjects; and to assess the variability in randomization eligibility and treatment patterns.
Status: Completed Start Date: October 2010 Completion Date: September 2012
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Clinical trials allow volunteers access to medical treatment options before they are available to the general public. Participants often receive the best healthcare available for their condition.

Risks are a reality, however, and may include more frequent doctor visits, health risks (possibly life-threatening), and/or the treatment being ineffective. Trials are federally regulated with strict guidelines to protect participants.

Abbott Vascular Clinical Trials Information presented on ClinicalTrialsSearch.org is not intended to be a substitute for qualified medical advice visit or treatment with a real physician. We are not physicians. Always consult with a medical doctor (MD). ClinicalTrialsSearch.org is a website dedicated to listing clinical research studies in human subjects, including those specifically related to Abbott Vascular. Clinical research trials and medical trials take place in hundreds of cities across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectiveness of new treatments and drugs. The purpose of the studies is to answer specific human health questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions. Clinical trials allow volunteers access to medical treatment options before they are available to the general public. Many times the participants receive treatment for free, and sometimes they are paid for their time. Participants often receive the best healthcare available possible for their condition. Risks are a reality, however, and may include more frequent doctor visits, health risks (possibly life-threatening), and/or the treatment being ineffective. U.S. - based Abbott Vascular studies are federally regulated with strict guidelines to protect patients.

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