CompletedNCT01583608ASSUREUpdated Dec 9, 2016

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

An observational study in Cardiovascular Diseases, Coronary Artery Disease and Myocardial Ischemia, sponsored by Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.. Completed at 6 sites in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-12-09.

Sponsored by Medical Care Center Prof. Mathey, Prof. Schofer, Ltd. · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 183
Ages: 18 Years to 75 Years
Sex: All

Study 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.

Read the 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 studied

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

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Keywords

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

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 183 is below the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Medical Care Center Prof. Mathey, Prof. Schofer, Ltd. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Patients with cardiovascular disease

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

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 183 participants (actual)

What researchers measure

Primary outcomes

(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
Time frame: at 24 months

Secondary outcomes

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.
Time frame: 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.
Time frame: At time of intervention
Scaffold thrombosis
Time frame: At time of intervention, and at 6, 12, 24, 36 months
Cardiac death
Time frame: At time of intervention, and at 6, 12,24, 36 months
Myocardial infarction
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: at 6, 12, 24, 36 months
Ischemia driven target vessel failure (TVF)
Time frame: at 6, 12, 24, 36 month
In-lesion % diameter stenosis
Time frame: Prior procedure
In-scaffold % diameter stenosis
Time frame: At time of intervention and at angiographic FU if applicable
Minimal lumen diameter (MLD)
Time frame: Prior and post procedure and at FU if applicable
In-scaffold late lumen loss (LLL)
Time frame: At angiographic follow-up if applicable
Proximal and distal late lumen loss (LLL)
Time frame: At angiographic follow-up if applicable
In-lesion late lumen loss
Time frame: At angiographic follow-up if applicable
Response to nitroglycerin
Time frame: Before scaffold implantation, during angiographic follow-up if applicable
In-lesion angiographic binary restenosis (≥ 50%)
Time frame: At angiographic follow-up if applicable
Curvature (cm-1)
treated region
Time frame: Prior and post procedure and at angiographic follow-up if applicable
Angulation (°)
Treated region
Time frame: Prior and post procedure and at angiographic follow-up if applicable
Clinical success
Procedural success and freedom from TVF, TVR, CABG and scaffold thrombosis
Time frame: At time of intervention, and at 6, 12, 24, 36 months
Coronary artery bypass grafting (CABG)
Time frame: at 6, 12, 24, 36 month

Study locations

6 sites

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

References and documents

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. PubMed 21958884 ↗
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. PubMed 21959320 ↗
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. PubMed 21737016 ↗
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. PubMed 21777888 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01583608
Lead sponsor: Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Collaborators: Abbott Medical Devices
Responsible party: Detlef Mathey (Professor Dr. med. D. Mathey, Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.) — Principal investigator
First posted: Apr 24, 2012
Start date: Apr 2012
Primary completion: Mar 2013
Completion: Jun 2016
Last update: Dec 9, 2016

Study contacts

Detlef G Mathey, MD

principal investigator · Medical Care Center Prof. Mathey, Prof. Schofer GmbH

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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