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

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ClinicalTrials.gov Identifier: NCT02066623
Recruitment Status : Active, not recruiting
First Posted : February 19, 2014
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Coronary Artery Stenosis Device: ABSORB 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

Study Design

Study Type : Observational [Patient Registry]
Actual Enrollment : 3330 participants
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
Study Start Date : November 2013
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Everolimus
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Number of serious adverse cardiac events [ Time Frame: 5 years after index procedure ]

    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 :
  1. Success of ABSORB implantation [ Time Frame: during implantation of ABSORB scaffold ]

    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:
  1. Effectiveness of ABSORB implantation [ Time Frame: 5 years follow-up period ]

    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.


  2. Change in quality of life [ Time Frame: 5 years follow-up period ]

    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)

  3. Health-economical effects of ABSORB scaffold implantation [ Time Frame: 5 years follow-up period ]

    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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02066623


  Show 81 Study Locations
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

Publications:
Responsible Party: IHF GmbH - Institut für Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT02066623     History of Changes
Other Study ID Numbers: GABI-R
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

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

Additional relevant MeSH terms:
Constriction, Pathologic
Coronary Stenosis
Pathological Conditions, Anatomical
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents