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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00300131
First received: March 7, 2006
Last updated: September 9, 2011
Last verified: September 2011

March 7, 2006
September 9, 2011
March 2006
July 2011   (final data collection date for primary outcome measure)
  • Ischemia Driven MACE [ Time Frame: at 30, 180, 270 days, and 1, 2, 3, 4, 5 years; ] [ Designated as safety issue: Yes ]
  • Ischemia driven Target Vessel Failure (TVF) [ Time Frame: at 30, 180, 270 days, and 1, 2, 3, 4, 5 years; ] [ Designated as safety issue: Yes ]
  • Acute success (clinical device and clinical procedure) [ Time Frame: Acute ] [ Designated as safety issue: Yes ]
  • Ischemia Driven Target Lesion Revascularization (TLR) [ Time Frame: at 30, 180, 270 days and 1, 2, 3, 4, 5 years; ] [ Designated as safety issue: Yes ]
  • Ischemia Driven Target Vessel Revascularization (TVR) [ Time Frame: at 30, 180, 270 days and 1, 2, 3, 4, 5 years ] [ Designated as safety issue: Yes ]
  • • 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)
Complete list of historical versions of study NCT00300131 on ClinicalTrials.gov Archive Site
  • In-stent Late Loss(LL) [ Time Frame: at 180 days and 2 years ] [ Designated as safety issue: Yes ]
  • In-segment LL [ Time Frame: at 180 days and 2 years ] [ Designated as safety issue: Yes ]
  • Proximal LL (proximal defined as within 5 mm of tissue proximal to stent placement) [ Time Frame: at 180 days and 2 years ] [ Designated as safety issue: Yes ]
  • Distal LL (distal defined as within 5 mm of tissue distal to stent placement) [ Time Frame: at 180 days and 2 years ] [ Designated as safety issue: Yes ]
  • In-stent and in-segment Angiographic Binary Restenosis (ABR) rate [ Time Frame: at 180 days and 2 years ] [ Designated as safety issue: Yes ]
  • In-stent % Volume Obstruction (VO) [ Time Frame: at 180 days and 2 years ] [ Designated as safety issue: Yes ]
  • Persisting incomplete apposition, late incomplete apposition, aneurysm, thrombus, persisting dissection [ Time Frame: at 180 days and 2 years ] [ Designated as safety issue: Yes ]
  • • 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
Not Provided
Not Provided
 
ABSORB Clinical Investigation, Cohort A (ABSORB A) Everolimus Eluting Coronary Stent System Clinical Investigation
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

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.

  • 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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with coronary artery disease

  • Coronary Disease
  • Coronary Artery Disease
  • Coronary Restenosis
Device: Bioabsorbable Everolimus Eluting Coronary Stent
Bioabsorbable drug eluting stent implantation stent in the treatment of coronary artery disease
Other Name: BVS
1
Bioabsorbable Vascular Solutions (BVS) Everolimus Eluting Coronary Stent System
Intervention: Device: Bioabsorbable Everolimus Eluting Coronary Stent

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2011
July 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Netherlands,   New Zealand,   Poland
 
NCT00300131
05-370
Yes
Abbott Vascular
Abbott Vascular
Not Provided
Principal Investigator: John Ormiston, MD Auckland City Hospital
Principal Investigator: Patrick Serruys, MD Erasmus University Thorax Center
Abbott Vascular
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP