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

Completed

• Conditions: Coronary Disease; Coronary Artery Disease; Coronary Restenosis

• 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

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)

Skejby Sygehus; 🇩🇰 Aarhus, Denmark

Erasmus University Thorax Center; 🇳🇱 Rotterdam, Netherlands

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

University Hospital; 🇵🇱 Krakow, Poland