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ABSORB Clinical Investigation, Cohort A (ABSORB A) Everolimus Eluting Coronary Stent System Clinical Investigation (ABSORB A)

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ClinicalTrials.gov Identifier: NCT00300131
Recruitment Status : Completed
First Posted : March 8, 2006
Last Update Posted : September 13, 2011
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date March 7, 2006
First Posted Date March 8, 2006
Last Update Posted Date September 13, 2011
Study Start Date March 2006
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 17, 2007)
  • Ischemia Driven MACE [ Time Frame: at 30, 180, 270 days, and 1, 2, 3, 4, 5 years; ]
  • Ischemia driven Target Vessel Failure (TVF) [ Time Frame: at 30, 180, 270 days, and 1, 2, 3, 4, 5 years; ]
  • Acute success (clinical device and clinical procedure) [ Time Frame: Acute ]
  • Ischemia Driven Target Lesion Revascularization (TLR) [ Time Frame: at 30, 180, 270 days and 1, 2, 3, 4, 5 years; ]
  • Ischemia Driven Target Vessel Revascularization (TVR) [ Time Frame: at 30, 180, 270 days and 1, 2, 3, 4, 5 years ]
Original Primary Outcome Measures
 (submitted: March 7, 2006)
  • • Ischemia Driven MACE at 30, 180, 270 days, and 1, 2, 3, 4, 5 years
  • • Ischemia driven Target Vessel Failure (TVF) at 30, 180, 270 days, and 1, 2, 3, 4, 5 years
  • • Acute success (clinical device and clinical procedure)
Change History
Current Secondary Outcome Measures
 (submitted: July 17, 2007)
  • In-stent Late Loss(LL) [ Time Frame: at 180 days and 2 years ]
  • In-segment LL [ Time Frame: at 180 days and 2 years ]
  • Proximal LL (proximal defined as within 5 mm of tissue proximal to stent placement) [ Time Frame: at 180 days and 2 years ]
  • Distal LL (distal defined as within 5 mm of tissue distal to stent placement) [ Time Frame: at 180 days and 2 years ]
  • In-stent and in-segment Angiographic Binary Restenosis (ABR) rate [ Time Frame: at 180 days and 2 years ]
  • In-stent % Volume Obstruction (VO) [ Time Frame: at 180 days and 2 years ]
  • Persisting incomplete apposition, late incomplete apposition, aneurysm, thrombus, persisting dissection [ Time Frame: at 180 days and 2 years ]
Original Secondary Outcome Measures
 (submitted: March 7, 2006)
  • • Ischemia Driven Target Lesion Revascularization (TLR) at 30, 180, 270 days and 1, 2, 3, 4, 5 years
  • • Ischemia Driven Target Vessel Revascularization (TVR) at 30, 180, 270 days and 1, 2, 3, 4, 5 years
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ABSORB Clinical Investigation, Cohort A (ABSORB A) Everolimus Eluting Coronary Stent System Clinical Investigation
Official Title Bioabsorbable Vascular Solutions First in Man Clinical Investigation: A Clinical Evaluation of the Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS) in the Treatment of Patients With Single de Novo Native Coronary Artery Lesions
Brief Summary Prospective, open-labeled First in Man Clinical Investigation enrolling patients with visually estimated nominal vessel diameter of 3.0 mm receiving a single 3.0 x 12 mm or 3.0 x 18 mm BVS EECSS containing 98 microgramme per cm² of surface area.
Detailed Description
  • Prospective, open-labeled Clinical Investigation enrolling patients with visually estimated nominal vessel diameter of 3.0 mm and lesion length ≥ 8 mm receiving a single 3.0 x 12 mm BVS Everolimus Eluting CSS containing 98 microgramme per cm² of surface area. Lesion length will be expanded to≥ 14 mm in length by visual estimation when 3.0 x 18 mm stent is available.
  • Angiographic, Intravascular Ultrasound (IVUS), Intravascular Ultrasound- virtual histology (IVUS-VH) and Palpography follow-up will be carried out in all patients at 180 days and 2 years following the index procedure
  • Optical Coherence Tomography (OCT) follow-up at 180 days and 2 years will be carried out in a subset of up to 10 patients in Cohorts A and B respectively who are enrolled in pre-determined clinical site(s)
  • Multi-slice Spiral Computed Tomography (MSCT) is an optional procedure which may be carried out at 18 months post procedure and again between 4 and 5 year follow up.
  • Additionally, coronary vasomotion test may be done at 2 years post procedure

Single patient Cohort of 30.

Pipeline products. Currently in development at Abbott Vascular. Not available for sale.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with coronary artery disease
Condition
  • Coronary Disease
  • Coronary Artery Disease
  • Coronary Restenosis
Intervention Device: Bioabsorbable Everolimus Eluting Coronary Stent
Bioabsorbable drug eluting stent implantation stent in the treatment of coronary artery disease
Other Name: BVS
Study Groups/Cohorts 1
Bioabsorbable Vascular Solutions (BVS) Everolimus Eluting Coronary Stent System
Intervention: Device: Bioabsorbable Everolimus Eluting Coronary Stent
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 16, 2009)
30
Original Enrollment
 (submitted: March 7, 2006)
60
Actual Study Completion Date July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Target lesion must be located in a native epicardial vessel with visually estimated nominal vessel diameter of 3.0 mm

  • Target lesion must measure less/equal 8 mm in length by visual estimation for 3.0 x 12 mm, expanded to less/equal 14 mm in length by visual estimation when 3.0 x 18 mm stent is available
  • The target lesion(s) must be in a major artery or branch with a visually estimated stenosis of > 50% and < 100% with a TIMI flow of greater/equal 1
  • Non-Clinical Investigation, percutaneous intervention for lesions in a non-target vessel is allowed if done more/equal 90 days prior to or if planned to be done 6 months after the index procedure
  • Non-Clinical Investigation, percutaneous intervention for lesions in the target vessel is allowed if done > 6 months prior to or if planned to be done 6 months after the index procedure

Exclusion Criteria:

  • Located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft
  • Lesion involving a bifurcation greater/equal 2 mm in diameter and ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation
  • Total occlusion (TIMI flow 0), prior to wire passing
  • The target vessel contains visible thrombus
  • Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion
  • Patient has received brachytherapy in any epicardial vessel (including side branches)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark,   Netherlands,   New Zealand,   Poland
Removed Location Countries Belgium,   France
 
Administrative Information
NCT Number NCT00300131
Other Study ID Numbers 05-370
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor Abbott Medical Devices
Collaborators Not Provided
Investigators
Principal Investigator: John Ormiston, MD Auckland City Hospital
Principal Investigator: Patrick Serruys, MD Erasmus University Thorax Center
PRS Account Abbott Medical Devices
Verification Date September 2011