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ABSORB FIRST is a Registry Designed to Evaluate the Safety and Performance of Absorb Bioresorbable Vascular Scaffold (Absorb BVS) Used in Real-world Patients.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01759290
First received: December 14, 2012
Last updated: August 26, 2016
Last verified: August 2016

December 14, 2012
August 26, 2016
January 2013
August 2015   (final data collection date for primary outcome measure)
Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) [ Time Frame: 0 to 407 days ] [ Designated as safety issue: Yes ]
Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
  • Clinical Device success (lesion based analysis) [ Time Frame: From start of index procedure to end of index procedure. ] [ Designated as safety issue: No ]

    Achievement of a final in-scaffold residual diameter stenosis of < 50% assessed by online quantitative angiography or visual estimation, using Absorb BVS and without a device deficiency.

    Time Frame: On a per device basis, the achievement of successful delivery and deployment of the study device(s) at the intended target lesion and successful withdrawal of the delivery catheter.

    This study has no primary endpoint. All endpoints are equivalent.

  • Clinical Procedure Success [ Time Frame: During the hospital stay with a maximum of 3 days post index procedure. ] [ Designated as safety issue: No ]

    Achievement of a final in-scaffold diameter stenosis of < 50% by online QCA or visual estimation using Absorb BVS, with or without any adjunctive devices, and without the occurrence of cardiac death, target vessel MI (Q-wave and non Q-wave MI), or repeat revascularization of the target lesion within 3 days of the index procedure.

    This study has no primary endpoint. All endpoints are equivalent.

Complete list of historical versions of study NCT01759290 on ClinicalTrials.gov Archive Site
  • Acute Success: Clinical Device Success (Lesion Level Analysis) [ Time Frame: < or = 1 day ] [ Designated as safety issue: No ]
    Device success was defined as the achievement of a final in-scaffold residual diameter stenosis of <50% assessed by online quantitative angiography or visual estimation, using Absorb BVS and without a device deficiency. A device was considered to have failed if it did not meet the requirements of the definition for clinical device success.
  • Acute Success: Clinical Procedure Success (Per Subject Analysis) [ Time Frame: During the hospital stay with a maximum of 3 days post index procedure ] [ Designated as safety issue: No ]
    Procedure success was defined as the achievement of a final in-scaffold diameter stenosis of <50% by online quantitative coronary angiography (QCA) or visual estimation using Absorb BVS, with or without any adjunctive devices, and without the occurrence of cardiac death, target vessel MI (Q-wave and non-Q-wave MI), or repeat revascularization of the target lesion within 3 days of the index procedure.
  • Acute Scaffold Thrombosis [ Time Frame: <1 day ] [ Designated as safety issue: Yes ]
  • Subacute ScaffoldThrombosis [ Time Frame: 1 to 30 days ] [ Designated as safety issue: Yes ]
  • Late Scaffold Thrombosis [ Time Frame: 31 to 365 Days ] [ Designated as safety issue: Yes ]
  • All Death, All MI, All Revascularization (DMR) [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
    Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
  • Major Adverse Cardiac Event (MACE) [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
    MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
  • Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
    Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
  • Cardiac Death/All MI [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
  • All Death/All MI [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
  • All Death, All MI, All Revascularization (DMR) [ Time Frame: 0 to 37 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) [ Time Frame: 0 to 37 days ] [ Designated as safety issue: Yes ]
    Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
  • Major Adverse Cardiac Event (MACE) [ Time Frame: 0 - 37 Days ] [ Designated as safety issue: Yes ]
    MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
  • Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) [ Time Frame: 0 to 37 Days ] [ Designated as safety issue: Yes ]
    Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
  • Cardiac Death/All MI [ Time Frame: 0 to 37 days ] [ Designated as safety issue: Yes ]
  • All Death/All MI [ Time Frame: 0 to 37 days ] [ Designated as safety issue: Yes ]
  • All Death, All MI, All Revascularization (DMR) [ Time Frame: 0 to 180 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) [ Time Frame: 0 to 180 days ] [ Designated as safety issue: Yes ]
    Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
  • Major Adverse Cardiac Event (MACE) [ Time Frame: 0 to 180 Days ] [ Designated as safety issue: Yes ]
    MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
  • Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) [ Time Frame: 0 to 180 Days ] [ Designated as safety issue: Yes ]
    Target Lesion Failure includes Cardiac Death,Target Vessel-Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
  • Cardiac Death/All MI [ Time Frame: 0 to 180 days ] [ Designated as safety issue: Yes ]
  • All Death/All MI [ Time Frame: 0 to 180 days ] [ Designated as safety issue: Yes ]
  • All Death, All MI, All Revascularization (DMR) [ Time Frame: 0 to 407 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF) [ Time Frame: 0 to 407 days ] [ Designated as safety issue: Yes ]
    Target Vessel Failure (TVF) includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Vessel Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
  • Major Adverse Cardiac Event (MACE) [ Time Frame: 0 to 407 Days ] [ Designated as safety issue: Yes ]
    MACE includes Cardiac Death, All Myocardial Infarction and Ischemic Driven-Target Lesion Revascularization. This is one of the Composite Clinical Endpoints (Safety and Efficacy, hierarchical).
  • Cardiac Death/All MI [ Time Frame: 0 to 407 days ] [ Designated as safety issue: Yes ]
  • All Death/All MI [ Time Frame: 0 to 407 days ] [ Designated as safety issue: Yes ]
  • Death (Cardiovascular, Non-Cardiovascular) [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
    This is one of the Safety Component (non-hierarchical) endpoints.
  • All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
    This is one of the Safety Component (non-hierarchical) endpoints.
  • Target Lesion Revascularization (TLR): All TLR [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.
  • Target Lesion Revascularization : Ischemia-Driven (ID-TLR) [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.
  • Target Vessel Revascularization (TVR): All TVR [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.
  • Target Vessel Revascularization : Ischemic-driven (ID-TVR) [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.
  • All Revascularization [ Time Frame: 0 to 7 days (In-hospital) ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.
  • Death (Cardiovascular, Non-Cardiovascular) [ Time Frame: 0 to 37 days ] [ Designated as safety issue: Yes ]
    This is one of the Safety Component (non-hierarchical) endpoints.
  • All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). [ Time Frame: 0 to 37 days ] [ Designated as safety issue: Yes ]
    This is one of the Safety Component (non-hierarchical) endpoints.
  • Target Lesion Revascularization (TLR): All TLR [ Time Frame: 0 to 37 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.
  • Target Lesion Revascularization : Ischemia-Driven (ID-TLR) [ Time Frame: 0 to 37 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.
  • Target Vessel Revascularization (TVR): All TVR [ Time Frame: 0 to 37 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.
  • Target Vessel Revascularization : Ischemic-driven (ID-TVR) [ Time Frame: 0 to 37 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.
  • All Revascularization [ Time Frame: 0 to 37 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.
  • Death (Cardiovascular, Non-Cardiovascular) [ Time Frame: 0 to 180 days ] [ Designated as safety issue: Yes ]
    This is one of the Safety Component (non-hierarchical) endpoints.
  • All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). [ Time Frame: 0 to 180 days ] [ Designated as safety issue: Yes ]
    This is one of the Safety Component (non-hierarchical) endpoints.
  • Target Lesion Revascularization (TLR): All TLR [ Time Frame: 0 to 180 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.
  • Target Lesion Revascularization : Ischemia-Driven (ID-TLR) [ Time Frame: 0 to 180 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.
  • Target Vessel Revascularization (TVR): All TVR [ Time Frame: 0 to 180 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.
  • Target Vessel Revascularization : Ischemic-driven (ID-TVR) [ Time Frame: 0 to 180 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.
  • All Revascularization [ Time Frame: 0 to 180 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.
  • Death (Cardiovascular, Non-Cardiovascular) [ Time Frame: 0 to 407 days ] [ Designated as safety issue: Yes ]
    This is one of the Safety Component (non-hierarchical) endpoints.
  • All Myocardial Infarction (MI): Q-wave MI (QMI) and Non-QMI (NQMI), TV, and Non-TV (NTV). [ Time Frame: 0 to 407 days ] [ Designated as safety issue: Yes ]
    This is one of the Safety Component (non-hierarchical) endpoints.
  • Target Lesion Revascularization (TLR): All TLR [ Time Frame: 0 to 407 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.
  • Target Lesion Revascularization : Ischemia-Driven (ID-TLR) [ Time Frame: 0 to 407 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.
  • Target Vessel Revascularization (TVR): All TVR [ Time Frame: 0 to 407 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.
  • Target Vessel Revascularization : Ischemic-driven (ID-TVR) [ Time Frame: 0 to 407 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.
  • All Revascularization [ Time Frame: 0 to 407 days ] [ Designated as safety issue: Yes ]
    This is one of the Efficacy Component (non-hierarchical) endpoints.
Not Provided
Not Provided
  • Death (Cardiovascular, Non-Cardiovascular) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    subset of patients
  • Death (Cardiovascular, Non-Cardiovascular) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Death (Cardiovascular, Non-Cardiovascular) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Death (Cardiovascular, Non-Cardiovascular) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Myocardial Infarction (MI: QMI and NQMI, TV, NTV ) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction (MI: QMI and NQMI, TV, NTV ) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Myocardial Infarction (MI: QMI and NQMI, TV, NTV ) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Myocardial Infarction (MI: QMI and NQMI, TV, NTV ) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Target Lesion Revascularization, all (TLR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Target Lesion Revascularization, all (TLR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Target Lesion Revascularization, all (TLR) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Target Lesion Revascularization, all (TLR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Target Lesion Revascularization, ischemic-driven (ID-TLR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Target Lesion Revascularization, ischemic-driven (ID-TLR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Target Lesion Revascularization, ischemic-driven (ID-TLR) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Target Lesion Revascularization, ischemic-driven (ID-TLR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Target Vessel Revascularization, all (TVR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization, all (TVR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Target Vessel Revascularization, all (TVR) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Target Vessel Revascularization, all (TVR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Target Vessel Revascularization, ischemic-driven (ID-TVR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization, ischemic-driven (ID-TVR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Target Vessel Revascularization, ischemic-driven (ID-TVR) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Target Vessel Revascularization, ischemic-driven (ID-TVR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • All coronary revascularizations (PCI vs. CABG) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • All coronary revascularizations (PCI vs. CABG) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • All coronary revascularizations (PCI vs. CABG) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • All coronary revascularizations (PCI vs. CABG) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure [TLF]) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure [TLF]) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure [TLF]) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure [TLF]) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Cardiac Death/All MI/ID-TLR [MACE]) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR [MACE]) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Cardiac Death/All MI/ID-TLR [MACE]) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Cardiac Death/All MI/ID-TLR [MACE]) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Cardiac Death/All MI/ID-TVR (Target Vessel Failure [TVF]) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TVR (Target Vessel Failure [TVF]) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Cardiac Death/All MI/ID-TVR (Target Vessel Failure [TVF]) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Cardiac Death/All MI/ID-TVR (Target Vessel Failure [TVF]) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    subset of patients
  • Scaffold/Stent Thrombosis Timing (acute) [ Time Frame: within 24 hours of index procedure ] [ Designated as safety issue: Yes ]
    Definite, Probable
  • Scaffold/Stent Thrombosis Timing (sub-acute) [ Time Frame: >24 hours to 30 days ] [ Designated as safety issue: Yes ]
    Definite, Probable
  • Scaffold/Stent Thrombosis Timing (late) [ Time Frame: >30 days to 1 year ] [ Designated as safety issue: Yes ]
    Definite, Probable
  • Scaffold/Stent Thrombosis Timing (very late) [ Time Frame: >1 year ] [ Designated as safety issue: Yes ]
 
ABSORB FIRST is a Registry Designed to Evaluate the Safety and Performance of Absorb Bioresorbable Vascular Scaffold (Absorb BVS) Used in Real-world Patients.
ABSORB FIRST Registry: An International Post-market Registry of Patients With de Novo Lesions in Previously Untreated Vessels Treated With Absorb Bioresorbable Vascular Scaffold (Absorb BVS).

ABSORB FIRST is a prospective, multi-center registry. The objectives of the study are to:

  • Provide ongoing post-market surveillance for documentation of safety, performance and clinical outcomes of the Absorb BVS (Bioresorbable Vascular Scaffold) System in daily percutaneous coronary intervention (PCI) practice per Instructions for Use (IFU, on-label use).
  • To evaluate the safety and performance of 12 mm or shorter Absorb BVS in single or overlapping use (bailout, optimization of long lesion treatment) for the treatment of patients with ischemic heart disease caused by de novo native coronary artery lesion(s)
  • Collect additional information (e.g. acute success) to evaluate handling and implantation of Absorb BVS by physicians under a wide range of commercial use conditions and following routine clinical practice.

the ABSORB FIRST Registry is intended to provide an assessment of the safety and performance of the Absorb BVS device in accordance to the IFU in real world use involving more complex patients, lesions and use (examples: longer lesions, overlapping use, bailout, patients at high risks for cardiac events, etc.).

The ABSORB FIRST study will register a minimum of 1800 patients in approximately 90 sites throughout multiple countries worldwide where Absorb BVS has regulatory approval or is commercially available.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
1 Year
Not Provided
Non-Probability Sample
Patients enrolled into this registry will be male and female patients derived from the general interventional cardiology population who satisfy the inclusion and exclusion criteria.
  • Chronic Total Occlusion of Coronary Artery
  • Coronary Occlusion
  • Coronary Artery Disease
  • Coronary Artery Restenosis
  • Coronary Artery Stenosis
  • Coronary Disease
  • Coronary Restenosis
Device: Absorb Bioresorbable Vascular Scaffold
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
Absorb Bioresorbable Vascular Scaffold
Subjects receiving the Absorb Bioresorbable Vascular Scaffold
Intervention: Device: Absorb Bioresorbable Vascular Scaffold
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1800
December 2015
August 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The inclusion criteria must follow the most recent IFU which may include but are not limited to the following:

    • Patient must be at least 18 years of age at the time of signing the Informed Consent Form
    • Patient is to be treated for de novo lesions located in previously untreated vessels.
    • Patient must agree to undergo all required follow-up visits and data collection.

Exclusion Criteria:

  • The exclusion criteria must follow the most recent IFU which may include but are not limited to the following:

    • Inability to obtain a signed informed consent from potential patient.
    • Patient belongs to a vulnerable population (per investigator's judgment, this also includes people with a direct link (hierarchical or financial benefit) to the registry Doctor or the registry Sponsor).
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01759290
12-302
No
Not Provided
Not Provided
Abbott Vascular
Abbott Vascular
Not Provided
Principal Investigator: Ashok Seth, MD Fortis Escorts Heart Institute, New Delhi
Principal Investigator: Eric Eeckhout, MD, PhD Centre Hospitalier Universitaire Vaudois
Study Director: Peter Staehr, MD Abbott Vascular
Study Director: Vivian Mao, MD, MPH Clinical Science
Abbott Vascular
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP