ABSORB: Postmarketing Surveillance Registry to Monitor the Everolimus-eluting Bioresorbable Vascular Scaffold in Patients With Coronary Artery Disease (ASSURE)

ABSORB: Initial Clinical Experience With the Everolimus-eluting Bioresorbable Vascular Scaffold (BVS) System in the Treatment of de Novo Native Coronary Artery Lesions - a Surveillance Registry

The registry aims to evaluate the safety, performance and efficacy of the Everolimus-eluting bioresorbable vascular scaffold (BVS) system in patients with de novo native coronary artery lesions in all-day clinical practice.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Artery Disease; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Stenosis; Coronary Restenosis

Detailed Description

Bioresorbable scaffolds are transient implants. They act like drug-eluting metallic stents (DES) during the first 3 months by supporting the vessel wall thereby keeping the artery patent. Subsequently, resorption of the scaffold begins and its structure loosens. As a result of everolimus release, neointimal growth is inhibited similar to DES. Finally the implant is reabsorbed completely in about 2-3 years. BVS in terms of late stent thrombosis may be safer than DES. Transiently scaffolded vessels may regain their natural curvature and angulation as well as response to nitroglycerine and endothelial function.

• Study Type: Observational
• Enrollment (Actual): 183

Contacts and Locations

Study Locations

• Germany
  • Bernau, Germany, 16321
    • Herzzentrum Brandenburg in Bernau
  • Coburg, Germany, 96450
    • Klinikum Coburg GmbH
  • Essen, Germany, 45138
    • Elisabeth-Krankenhaus Essen GmbH
  • Hamburg, Germany, 22527
    • Medical Care Center Prof. Mathey, Prof. Schofer GmbH
  • Kiel, Germany, 24105
    • Universitätsklinikum Schleswig-Holstein
  • Ulm, Germany, 89081
    • Universitatsklinikum Ulm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with cardiovascular disease

Description

The recommendation to implant BVS in an individual patient is purely based on clinical grounds. These are determined by the instructions for use (IFU) of the BVS and by the clinical experience accumulated so far from clinical studies.These studies suggest that the BVS should be implanted under certain conditions, which are determined by the patient and the coronary lesion treated:

Eligible:

Regarding to patient

• Patient ≥ 18 and ≤ 75 years with a live expectancy of at least 5 years with ischemic heart disease (chronic, NSTEMI and unstable angina) due to one or more de novo native coronary artery lesions
• Patients with evidence of myocardial ischemia

Regarding to lesion

• Reference vessel diameter ≥ 2.0 mm and ≤ 3.8 mm, visually estimated and by online QCA
• Percent diameter stenosis ≥ 50% and < 100%, visually estimated and by online QCA
• TIMI ≥1
• Previous interventions of target vessel lesions should have been done ≥ 6 months prior to index procedure and > 10 mm distal to the target lesion
• Previous interventions of non-target vessel lesions should have been done ≥ 30 days prior to index procedure
• In case of >1 target lesions, those should be from different epicardial vessels

Not eligible:

Regarding to patient

• Patient in whom antiplatelet therapy and/or anticoagulant therapy is contraindicated
• Patient with a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel, ticlopidine, prasugrel and ticagrelor, everolimus, poly (L-lactide), poly (D,L-lactide), or platinum, or with contrast sensitivity, who cannot be adequately premedicated
• Patient has a known diagnosis of acute myocardial infarction (STEMI) within 72 hours preceding the index procedure and CK and CK-MB have not returned within normal limits at the time of procedure
• Patient is currently experiencing clinical symptoms consistent with STEMI
• Patient has current unstable arrhythmias
• Patient has a known left ventricular ejection fraction < 30%
• Patient has received a heart transplant or any other organ transplant or is waiting for any organ transplant
• Patient receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after procedure
• Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease
• Patient is receiving or scheduled to receive chronic anticoagulation therapy
• Elective surgery is planned within the first 6 month after the procedure that will require discontinuing either aspirin or clopidogrel
• Patient has a platelet count < 100 000 cells/mm3 or > 700 000 cells/mm3, a WBC of
• < 3000 cells/mm3, or documented or suspected liver disease
• Patient has known renal insufficiency
• Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
• Patient has cerebrovascular accident or transient ischemic neurological attack within the past six month
• Patient has had a significant GI or urinary bleed within the past six months
• Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion
• Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non.compliance with the clinical study plan, confound the data interpretation or is associated with a limited life expectancy (i.e., les than one year)
• Women of childbearing potential who have not undergone surgical sterilization or are not post-menopausal

Regarding to lesion

• Aorto-ostial location
• Left main location
• Located within 2 mm of the origin of LAD or LCX
• 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 with side branch vessel ≥ 2 mm in diameter, ostial lesion > 40% stenosed by visual estimation or side branch requiring predilation
• Total occlusion (TIMI flow 0), prior to wire passing
• Excessive tortuosity proximal to or within the lesion (extreme angulation (≥ 90°) proximal to or within the lesion)
• Heavy calcification
• Restenotic from previous intervention
• Target vessel is containing thrombus

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(This trial has no primary outcome, all outcomes are of equal weight), Major Adverse Cardiac Event (MACE)	Composite of ischemia driven target lesion revascularisation (TLR), myocardial infarction and cardiac death	at 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute procedural success	Achievement of final in-scaffold residual stenosis of < 50% and TIMI flow 3 of the target site. Successful delivery and deployment of at least one study scaffold at the intended target lesion and successful withdrawal of the delivery system for all target lesions without occurrence of cardiac death, target vessel MI or repeat TLR during hospital stay (maximum of 7 days). In dual target lesion setting both lesions must meet clinical procedure success criteria.	At the end of hospital stay (maximum of 7 days)
Acute device success	Successful delivery and deployment of the first scaffold at the intended target lesion (in overlapping setting both planned scaffolds) and successful withdrawal of delivery system. Attainment of < 50 % residual stenosis and TIMI flow 3 of the target site, using the BVS without the need for other non- study stents.	At time of intervention
Scaffold thrombosis		At time of intervention, and at 6, 12, 24, 36 months
Cardiac death		At time of intervention, and at 6, 12,24, 36 months
Myocardial infarction		At time of intervention, and at 6, 12, 24 36 months
Ischemia driven target lesion revascularisation (TLR)	Target lesion denominates scaffolded segment and 5 mm beyond.	At time of intervention, and at 6, 12, 24, 36 months
Major Adverse Cardiac Event (MACE)	Composite of ischemia driven target lesion revascularisation (TLR), myocardial infarction and cardial death	At time of intervention, participants will be followed for the duration of hospital stay (an expected average of 3 days), at 6, 12, 36 months
Ischemia driven target vessel revascularisation (TVR)	TVR is ischemia driven.	at 6, 12, 24, 36 months
Ischemia driven target vessel failure (TVF)		at 6, 12, 24, 36 month
In-lesion % diameter stenosis		Prior procedure
In-scaffold % diameter stenosis		At time of intervention and at angiographic FU if applicable
Minimal lumen diameter (MLD)		Prior and post procedure and at FU if applicable
In-scaffold late lumen loss (LLL)		At angiographic follow-up if applicable
Proximal and distal late lumen loss (LLL)		At angiographic follow-up if applicable
In-lesion late lumen loss		At angiographic follow-up if applicable
Response to nitroglycerin		Before scaffold implantation, during angiographic follow-up if applicable
In-lesion angiographic binary restenosis (≥ 50%)		At angiographic follow-up if applicable
Curvature (cm-1)	treated region	Prior and post procedure and at angiographic follow-up if applicable
Angulation (°)	Treated region	Prior and post procedure and at angiographic follow-up if applicable
Clinical success	Procedural success and freedom from TVF, TVR, CABG and scaffold thrombosis	At time of intervention, and at 6, 12, 24, 36 months
Coronary artery bypass grafting (CABG)		at 6, 12, 24, 36 month

Collaborators and Investigators

• Sponsor: Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
• Collaborators: Abbott Medical Devices
• Investigators: Principal Investigator: Detlef G Mathey, MD, Medical Care Center Prof. Mathey, Prof. Schofer GmbH

Publications and helpful links

General Publications

• Serruys PW, Onuma Y, Dudek D, Smits PC, Koolen J, Chevalier B, de Bruyne B, Thuesen L, McClean D, van Geuns RJ, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Sudhir K, Garcia-Garcia HM, Ormiston JA. Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. J Am Coll Cardiol. 2011 Oct 4;58(15):1578-88. doi: 10.1016/j.jacc.2011.05.050.
• Dudek D, Onuma Y, Ormiston JA, Thuesen L, Miquel-Hebert K, Serruys PW. Four-year clinical follow-up of the ABSORB everolimus-eluting bioresorbable vascular scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2012 Jan;7(9):1060-1. doi: 10.4244/EIJV7I9A168.
• Diletti R, Onuma Y, Farooq V, Gomez-Lara J, Brugaletta S, van Geuns RJ, Regar E, de Bruyne B, Dudek D, Thuesen L, Chevalier B, McClean D, Windecker S, Whitbourn R, Smits P, Koolen J, Meredith I, Li D, Veldhof S, Rapoza R, Garcia-Garcia HM, Ormiston JA, Serruys PW. 6-month clinical outcomes following implantation of the bioresorbable everolimus-eluting vascular scaffold in vessels smaller or larger than 2.5 mm. J Am Coll Cardiol. 2011 Jul 12;58(3):258-64. doi: 10.1016/j.jacc.2011.02.052.
• Gomez-Lara J, Brugaletta S, Farooq V, van Geuns RJ, De Bruyne B, Windecker S, McClean D, Thuesen L, Dudek D, Koolen J, Whitbourn R, Smits PC, Chevalier B, Morel MA, Dorange C, Veldhof S, Rapoza R, Garcia-Garcia HM, Ormiston JA, Serruys PW. Angiographic geometric changes of the lumen arterial wall after bioresorbable vascular scaffolds and metallic platform stents at 1-year follow-up. JACC Cardiovasc Interv. 2011 Jul;4(7):789-99. doi: 10.1016/j.jcin.2011.04.009.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: April 17, 2012
• First Submitted That Met QC Criteria: April 20, 2012
• First Posted (Estimate): April 24, 2012

Study Record Updates

• Last Update Posted (Estimate): December 9, 2016
• Last Update Submitted That Met QC Criteria: December 8, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Stents; Coronary Artery Disease; Drug eluting stent; Angioplasty; Bioabsorbable; Coronary Stent; Bioresorbable; Scaffold; Stentthrombosis
• Additional Relevant MeSH Terms: Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Arteriosclerosis; Coronary Stenosis; Coronary Restenosis
• Other Study ID Numbers: BVS 12