Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Observational Study to Evaluate Short and Long-term Safety of the ABSORB Scaffold (GABI-R)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by IHF GmbH - Institut für Herzinfarktforschung
Sponsor:
Collaborator:
Abbott Vascular
Information provided by (Responsible Party):
IHF GmbH - Institut für Herzinfarktforschung
ClinicalTrials.gov Identifier:
NCT02066623
First received: January 20, 2014
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

The German-Austrian ABSORB Register shall provide an analysis of acute and long-term safety as well as therapy outcomes of the ABSORB (trade mark) bioresorbable vascular scaffold system in patients suffering from coronary artery disease.


Condition Intervention
Coronary Artery Stenosis
Device: ABSORB Scaffold

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: German-Austrian Register to Evaluate the Short and Long-term Safety and Therapy Outcomes of the ABSORB Everolimus-eluting Bioresorbable Vascular Scaffold System in Patients With Coronary Artery Stenosis

Resource links provided by NLM:


Further study details as provided by IHF GmbH - Institut für Herzinfarktforschung:

Primary Outcome Measures:
  • Number of serious adverse cardiac events [ Time Frame: 5 years after index procedure ] [ Designated as safety issue: Yes ]

    The following events will be evaluated:

    • Death
    • Myocardial infarction
    • Clinically motivated target vessel revascularization
    • Composite target parameter of the aforementioned events (MACE, major adverse cardiac event) as the primary target parameter
    • Stroke
    • Composite target parameter of the aforementioned events including stroke as the primary target parameter (MACCE, major adverse cardiac and cerebrovascular event)
    • Stent thrombosis


Secondary Outcome Measures:
  • Success of ABSORB implantation [ Time Frame: during implantation of ABSORB scaffold ] [ Designated as safety issue: Yes ]

    The following parameters will be evaluated to assess procedural outcome:

    • Technical success: If the residual stenosis is less than 30% in the ABSORB covered lesion segment at the end of the procedure based on visual estimation
    • Therapy success: Technical success and no periprocedural complications
    • Clinical success: Therapy success and no serious adverse cardiac (and cerebrovascular) events (MACE, MACCE)
    • TIMI (thrombolysis in myocardial infarction) flow pre and post implant
    • Sudden occlusion of side branch in the case of bifurcation stenosis
    • Optional: Quantitative coronary angiography (QCA) with index treatment: final in-scaffold and in-segment percentage diameter stenosis (%DS), reference vessel diameter


Other Outcome Measures:
  • Effectiveness of ABSORB implantation [ Time Frame: 5 years follow-up period ] [ Designated as safety issue: Yes ]

    Effectiveness of ABSORB implantation will be assessed based on the following parameters:

    * Target vessel failure (TVF): This includes cardiac death, target vessel myocardial infarction (Q-wave or non-Q-wave MI) or clinically motivated target vessel revascularization (TVR), percutaneous or surgical.


  • Change in quality of life [ Time Frame: 5 years follow-up period ] [ Designated as safety issue: No ]

    Changes in quality of life will be assessed by measuring

    • Angina pectoris scores (incl. CCS score, Canadian Cardiovascular Society score) and heart failure scores (NYHA, New York Heart Association score)
    • Standardized questionnaire for quality of life (EQ-5D)
    • Standardized questionnaire for health-related quality of life of patients with coronary artery disease (Seattle Angina Questionnaire, SAQ)

  • Health-economical effects of ABSORB scaffold implantation [ Time Frame: 5 years follow-up period ] [ Designated as safety issue: No ]

    Health-economical effects will be assessed by measuring

    • Direct costs: medication, visits to general practitioners and specialists, hospitalizations, inpatient and outpatient rehab, patient care services
    • Indirect costs: disability, reduced earning capacity


Estimated Enrollment: 5000
Study Start Date: November 2013
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Implantation of ABSORB Scaffold
Patients suffering from coronary artery stenosis with an indication for implantation of ABSORB scaffold
Device: ABSORB Scaffold
Implantation of a drug-eluting vascular scaffold, which is completely resorbable to improve the blood flow in coronary arteries in the presence of stenosis
Other Name: ABSORBTM Everolimus-eluting Bioresorbable Vascular Scaffold

Detailed Description:

The register collects prospective data regarding the quality of care of this therapy concept including specifically the following objectives:

  • Documentation of all consecutive patients having been treated with the ABSORB biore-sorbable vascular scaffold system under clinical real-world conditions
  • Documentation of indications, procedural results, and short and long-term outcomes
  • Documentation of the technical performance of ABSORB implant procedures
  • Collection of safety data, in particular documentation of hospital mortality, major non-fatal complications (especially myocardial infarction, Re-PCI (percutaneous coronary intervention) or CABG (coronary artery bypass grafting), stroke, thrombosis)
  • Documentation of long-term patient safety marked by mortality and major non-fatal complications (especially myocardial infarction, Re-PCI or CABG, stroke, thrombosis) at 30 days, 6 months, 2 years and 5 years
  • Gathering of health economics data (capture of direct costs, especially with view to change of medication and outpatient/inpatient hospital services, and indirect costs) pre and post ABSORB implant
  • Gathering data on the quality of life pre and post ABSORB implant to document individual QoL dimensions as well as QALY (quality adjusted life year) data
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients in Germany and Austria having been implanted with ABSORB scaffold system

Criteria

Inclusion Criteria:

  • ABSORB implant scheduled
  • Age 18+
  • Patients giving consent to keep scheduled follow-ups
  • Signed informed consent

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02066623

Contacts
Contact: Holger Nef, Prof. Dr. +49 (0) 641-985-42101 holger.nef@me.com

Locations
Germany
Segeberger Kliniken GmbH Recruiting
Bad Segeberg, Germany, 23795
Contact: Gert Richardt, Prof. Dr.       gert.richardt@segebergerkliniken.de   
University Clinic Giessen Recruiting
Giessen, Germany, 35392
Contact: Holger Nef, Prof. Dr.    +49 (0) 641-985-42101    holger.nef@me.com   
Herz- und Gefäßzentrum Oberallgäu/Kempten Recruiting
Kempten, Germany, 87439
Contact: Jan S Torzewski, Prof. Dr.       jan.torzewski@kliniken-oa.de   
Klinikum Ludwigshafen Recruiting
Ludwigshafen am Rhein, Germany, 67063
Contact: Ralf Zahn, Prof. Dr.       mb@klilu.de   
Sponsors and Collaborators
IHF GmbH - Institut für Herzinfarktforschung
Abbott Vascular
Investigators
Principal Investigator: Christian Hamm, Prof. Dr. University Clinic Giessen and Kerckhoff-Clinic Bad Nauheim
  More Information

No publications provided

Responsible Party: IHF GmbH - Institut für Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT02066623     History of Changes
Other Study ID Numbers: GABI-R
Study First Received: January 20, 2014
Last Updated: February 17, 2014
Health Authority: Germany: Ethics Commission
Austria: Austrian Society for Ultrasound in Medicine

Keywords provided by IHF GmbH - Institut für Herzinfarktforschung:
coronary artery stenosis, vascular scaffold, ABSORB

Additional relevant MeSH terms:
Constriction, Pathologic
Coronary Stenosis
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Pathological Conditions, Anatomical
Vascular Diseases
Everolimus
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 19, 2014