Clinical trial NCT01583608: ABSORB: Postmarketing Surveillance Registry to Monitor the Everolimus-eluting Bioresorbable Vascular Scaffold in Patients With Coronary Artery Disease
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2012-04-24
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cardiovascular disease

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.

Eligibility criteria: 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

Primary outcomes:
measure: (This trial has no primary outcome, all outcomes are of equal weight), Major Adverse Cardiac Event (MACE)
timeFrame: at 24 months
Secondary outcomes:
measure: Acute procedural success
timeFrame: At the end of hospital stay (maximum of 7 days)
measure: Acute device success
timeFrame: At time of intervention
measure: Scaffold thrombosis
timeFrame: At time of intervention, and at 6, 12, 24, 36 months
measure: Cardiac death
timeFrame: At time of intervention, and at 6, 12,24, 36 months
measure: Myocardial infarction
timeFrame: At time of intervention, and at 6, 12, 24 36 months
measure: Ischemia driven target lesion revascularisation (TLR)
timeFrame: At time of intervention, and at 6, 12, 24, 36 months
measure: Major Adverse Cardiac Event (MACE)
timeFrame: 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
measure: Ischemia driven target vessel revascularisation (TVR)
timeFrame: at 6, 12, 24, 36 months
measure: Ischemia driven target vessel failure (TVF)
timeFrame: at 6, 12, 24, 36 month
measure: In-lesion % diameter stenosis
timeFrame: Prior procedure
measure: In-scaffold % diameter stenosis
timeFrame: At time of intervention and at angiographic FU if applicable
measure: Minimal lumen diameter (MLD)
timeFrame: Prior and post procedure and at FU if applicable
measure: In-scaffold late lumen loss (LLL)
timeFrame: At angiographic follow-up if applicable
measure: Proximal and distal late lumen loss (LLL)
timeFrame: At angiographic follow-up if applicable
measure: In-lesion late lumen loss
timeFrame: At angiographic follow-up if applicable
measure: Response to nitroglycerin
timeFrame: Before scaffold implantation, during angiographic follow-up if applicable
measure: In-lesion angiographic binary restenosis (≥ 50%)
timeFrame: At angiographic follow-up if applicable
measure: Curvature (cm-1)
timeFrame: Prior and post procedure and at angiographic follow-up if applicable
measure: Angulation (°)
timeFrame: Prior and post procedure and at angiographic follow-up if applicable
measure: Clinical success
timeFrame: At time of intervention, and at 6, 12, 24, 36 months
measure: Coronary artery bypass grafting (CABG)
timeFrame: at 6, 12, 24, 36 month
Other outcomes:
Locations:
city: Bernau
country: Germany
facility: Herzzentrum Brandenburg in Bernau
city: Coburg
country: Germany
facility: Klinikum Coburg GmbH
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus Essen GmbH
city: Hamburg
country: Germany
facility: Medical Care Center Prof. Mathey, Prof. Schofer GmbH
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
Study officials:
affiliation: Medical Care Center Prof. Mathey, Prof. Schofer GmbH
name: Detlef G Mathey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.