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

Completed

• Conditions: Coronary Disease; Coronary Artery Disease; Coronary Restenosis
• Interventions: Device: Bioabsorbable Everolimus Eluting Coronary Stent

• Registration Number: NCT00300131
• Lead Sponsor: Abbott Medical Devices

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 Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-07
• Study First Submitted QC: 2006-03-07
• Study First Posted: 2006-03-08
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-09
• Last Update Posted: 2011-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Bioabsorbable Everolimus Eluting Coronary Stent	Bioabsorbable Vascular Solutions (BVS) Everolimus Eluting Coronary Stent System

Primary Outcome Measures

Name	Time	Method
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)	Acute
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
Ischemia Driven MACE	at 30, 180, 270 days, and 1, 2, 3, 4, 5 years;

Secondary Outcome Measures

Name	Time	Method
In-stent Late Loss(LL)	at 180 days and 2 years
In-segment LL	at 180 days and 2 years
Proximal LL (proximal defined as within 5 mm of tissue proximal to stent placement)	at 180 days and 2 years
Distal LL (distal defined as within 5 mm of tissue distal to stent placement)	at 180 days and 2 years
In-stent and in-segment Angiographic Binary Restenosis (ABR) rate	at 180 days and 2 years
In-stent % Volume Obstruction (VO)	at 180 days and 2 years
Persisting incomplete apposition, late incomplete apposition, aneurysm, thrombus, persisting dissection	at 180 days and 2 years

Trial Locations

Locations (4)

Erasmus University Thorax Center; 🇳🇱 Rotterdam, Netherlands

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

Skejby Sygehus; 🇩🇰 Aarhus, Denmark

University Hospital; 🇵🇱 Krakow, Poland