News | December 09, 2011

ABSORB II Trial Will Compare Abbott's Bioresorbable Stent to Metallic DES

December 9, 2011 — Abbott announced Thursday the initiation of ABSORB II, the first randomized, controlled, multi-center clinical trial evaluating the safety, efficacy and performance of the Absorb bioresorbable vascular scaffold (BVS). The Absorb BVS will be compared to the company's Xience Prime everolimus-eluting coronary stent system.

Approximately 500 patients with coronary artery disease will be enrolled at about 40 investigational sites in Europe and New Zealand. The first patient was enrolled by Philip MacCarthy, M.D., consultant cardiologist and clinical lead; and Jonathan Hill, M.D., consultant cardiologist, at King's College Hospital in London.

Absorb is a bioresorbable scaffold designed to treat a patient's blocked vessel and then fully dissolve, leaving the vessel free of a permanent metallic implant. Because a permanent implant is not left behind, naturally occurring vessel functions may be restored. The device has CE Mark and is authorized for sale in Europe for the treatment of coronary artery disease. In the United States, it is currently investigational and not available for sale.

"Absorb has the potential to be an important advancement in the field of interventional cardiology, as clinical trials of this dissolvable device to date suggest that a permanent implant may not be needed to restore and maintain blood flow to the heart," said Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands and primary investigator for the ABSORB II clinical trial. "The ABSORB II trial is designed to test unique endpoints to determine the differences between Absorb and a permanent metallic implant, which may provide us with valuable insight into the potential uses of bioresorbable technology in patients with coronary artery disease."

Patients will be randomized at a ratio of 2-to-1 (Absorb to Xience Prime). The primary endpoints of the trial are change in dimension of the lumen (interior of the vessel) over time and vasomotion (vessel movement) at the treated vessel segment; they will be assessed based on changes in the vessel diameter in response to a stimulus.

Clinical endpoints, including death, myocardial infarction (heart attack), target lesion revascularization, and scaffold/stent thrombosis, will be assessed at 30 and 180 days and at one, two and three years post-treatment. Quality-of-life measures will be assessed prior to treatment, at 180 days and at one, two and three years post-treatment.

"ABSORB II is the first head-to-head study to test our Absorb device compared to Xience Prime, a drug eluting metallic stent, in patients with coronary artery disease," said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, medical affairs, and chief medical officer, Abbott Vascular. "This is also the first trial to evaluate clinical endpoints that may be unique to a bioresorbable device, such as measuring the ability of the vessel to respond to normal blood pressure changes. The potential to restore a treated vessel back to a more natural state will also be assessed in this trial."

Absorb is made of polylactide, a proven biocompatible material commonly used in medical implants such as dissolvable sutures. Studies to date have shown the device restores blood flow by opening a blocked vessel and providing support to the vessel until it dissolves after approximately two years.

Abbott has completed one clinical trial called ABSORB and currently is conducting a second trial called ABSORB EXTEND to evaluate the device for the treatment of coronary artery disease. It is a large-scale, single-arm study that will evaluate Absorb in patients at up to 100 centers in Europe, Asia Pacific, Canada and Latin America. The trial will enroll approximately 1,000 patients with complex coronary artery disease.

For more information: www.abbott.com

Related Content

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Cardiovascular Clinical Studies | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init