ABSORB FIRST Registry: An International Post-market Registry of Patients With de Novo Lesions in Previously Untreated Vessels Treated With Absorb Bioresorbable Vascular Scaffold (Absorb BVS).
Sponsor study identifier
observational
1,800
1 country
1
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2015
Actual (reported)Study Completion
December 2015
Actual (reported)ABSORB FIRST is a prospective, multi-center registry. The objectives of the study are to:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 14, 2012
Actual (reported)January 2013
Date type not reportedThis date has not been verified as actual or estimated.
January 3, 2013
Actual (reported)August 2015
Actual (reported)December 2015
Actual (reported)October 19, 2016
Actual (reported)Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF))
Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
0 to 407 days
Acute Success: Clinical Device Success (Lesion Level Analysis)
< or = 1 day
Acute Success: Clinical Procedure Success (Per Subject Analysis)
During the hospital stay with a maximum of 3 days post index procedure
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients enrolled into this registry will be male and female patients derived from the general interventional cardiology population who satisfy the inclusion and exclusion criteria.
Abbott Vascular International BVBA
Brussels, 0886.537.933, Belgium
Ashok Seth, MD
Fortis Escorts Heart Institute, New Delhi
Eric Eeckhout, MD, PhD
Centre Hospitalier Universitaire Vaudois
Peter Staehr, MD
Abbott Medical Devices
Vivian Mao, MD, MPH
Clinical Science
1,800 participants (actual enrollment reported by the registry).
First Submitted
December 14, 2012
First Posted
January 3, 2013
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Acute Scaffold Thrombosis
<1 day
Subacute ScaffoldThrombosis
1 to 30 days
Late Scaffold Thrombosis
31 to 365 Days
Contact the study team to confirm eligibility.
Primary Completion
August 2015
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
October 19, 2016
Results First Posted
October 19, 2016
Record last verified: 2016-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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