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Cardiovascular DiseasesASSURENCT01583608

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

An observational study of Cardiovascular Diseases and Coronary Artery Disease, run by Medical Care Center Prof. Mathey, Prof. Schofer, Ltd. at 6 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 75 years
How many people
183 participants
Where
6 sitesGermany
Study dates
Apr 2012to Jun 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with cardiovascular disease

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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • Herzzentrum Brandenburg in Bernau

    Bernau, 16321

  • Klinikum Coburg GmbH

    Coburg, 96450

  • Elisabeth-Krankenhaus Essen GmbH

    Essen, 45138

  • Medical Care Center Prof. Mathey, Prof. Schofer GmbH

    Hamburg, Free and Hanseatic City of Hamburg, 22527

  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24105

  • Universitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

About this study

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

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.

Keywords
Drug eluting stent, Bioabsorbable, Bioresorbable, Coronary Stent, Scaffold, Stents, Angioplasty, Coronary Artery Disease, Stentthrombosis
Medical subject headings
Cardiovascular Diseases, Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Coronary Restenosis, Heart Diseases, Coronary Stenosis, Arteriosclerosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. (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

    Measured: at 24 months

Secondary outcomes (21)

  1. 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.

    Measured: At the end of hospital stay (maximum of 7 days)

  2. 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.

    Measured: At time of intervention

  3. Scaffold thrombosis

    Measured: At time of intervention, and at 6, 12, 24, 36 months

  4. Cardiac death

    Measured: At time of intervention, and at 6, 12,24, 36 months

  5. Myocardial infarction

    Measured: At time of intervention, and at 6, 12, 24 36 months

  6. Ischemia driven target lesion revascularisation (TLR)

    Target lesion denominates scaffolded segment and 5 mm beyond.

    Measured: At time of intervention, and at 6, 12, 24, 36 months

  7. Major Adverse Cardiac Event (MACE)

    Composite of ischemia driven target lesion revascularisation (TLR), myocardial infarction and cardial death

    Measured: 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

  8. Ischemia driven target vessel revascularisation (TVR)

    TVR is ischemia driven.

    Measured: at 6, 12, 24, 36 months

  9. Ischemia driven target vessel failure (TVF)

    Measured: at 6, 12, 24, 36 month

  10. In-lesion % diameter stenosis

    Measured: Prior procedure

  11. In-scaffold % diameter stenosis

    Measured: At time of intervention and at angiographic FU if applicable

  12. Minimal lumen diameter (MLD)

    Measured: Prior and post procedure and at FU if applicable

  13. In-scaffold late lumen loss (LLL)

    Measured: At angiographic follow-up if applicable

  14. Proximal and distal late lumen loss (LLL)

    Measured: At angiographic follow-up if applicable

  15. In-lesion late lumen loss

    Measured: At angiographic follow-up if applicable

  16. Response to nitroglycerin

    Measured: Before scaffold implantation, during angiographic follow-up if applicable

  17. In-lesion angiographic binary restenosis (≥ 50%)

    Measured: At angiographic follow-up if applicable

  18. Curvature (cm-1)

    treated region

    Measured: Prior and post procedure and at angiographic follow-up if applicable

  19. Angulation (°)

    Treated region

    Measured: Prior and post procedure and at angiographic follow-up if applicable

  20. Clinical success

    Procedural success and freedom from TVF, TVR, CABG and scaffold thrombosis

    Measured: At time of intervention, and at 6, 12, 24, 36 months

  21. Coronary artery bypass grafting (CABG)

    Measured: at 6, 12, 24, 36 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionMar 2013
  4. Study completionJun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
183 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01583608
Sponsor's protocol ID
BVS 12
Acronym
ASSURE
Status last verified
Dec 2016
First submitted
17 Apr 2012
Last updated
9 Dec 2016
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Coronary Artery Disease, run by Medical Care Center Prof. Mathey, Prof. Schofer, Ltd. at 6 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

(This trial has no primary outcome, all outcomes are of equal weight), Major Adverse Cardiac Event (MACE) (time frame: at 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01583608, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2016.

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