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

NCT ID: NCT01583608

Last Updated: 2016-12-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 183 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2016-06-30

Brief Summary

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.

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.

Conditions

Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Coronary Restenosis; Heart Diseases; Coronary Stenosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Keywords

Drug eluting stent; Bioabsorbable; Bioresorbable; Coronary Stent; Scaffold; Stents; Angioplasty; Coronary Artery Disease; Stentthrombosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: collaborator

Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Detlef Mathey

Professor Dr. med. D. Mathey

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Detlef G Mathey, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Care Center Prof. Mathey, Prof. Schofer GmbH

Locations

Medical Care Center Prof. Mathey, Prof. Schofer GmbH

Hamburg, City state of Hamburg, Germany

Herzzentrum Brandenburg in Bernau

Bernau, , Germany

Klinikum Coburg GmbH

Coburg, , Germany

Elisabeth-Krankenhaus Essen GmbH

Essen, , Germany

Universitätsklinikum Schleswig-Holstein

Kiel, , Germany

Universitätsklinikum Ulm

Ulm, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 21958884 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21959320 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21737016 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21777888 (View on PubMed)

Other Identifiers

BVS 12

Identifier Type: -

Identifier Source: org_study_id