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Completed

NCT Number: NCT01977534

To Study the Safety and Clinical Outcomes of the Absorb Bioresorbable Vascular Scaffold (BVS) System in Patients With de Novo Lesions in Previously Untreated Vessels

The purpose of this study is to determine the safety and clinical outcomes of the Absorb BVS for daily use in patients with de novo lesions in previously untreated vessels.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lister Hospital, Stevenage, Hertfordshire, United Kingdom

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About this study

ABSORB UK registry is a prospective, single arm, post-market registry designed to:

  • Provide ongoing post-market surveillance for documentation of safety and clinical outcomes of the Absorb Everolimus Eluting BVS System in daily percutaneous coronary intervention (PCI) practice per Instructions for Use (IFU, on-label use).
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ABSORB BVS

Device

The Absorb BVS System is a bioresorbable poly(L-lactide) (PLLA) scaffold with a drug and bioresorbable polymer coating [formulation of everolimus in a bioresorbable poly(D,L-lactide) (PDLLA) coating].

Primary outcomes

  1. Acute Success: Device success (lesion based analysis)

    Time frame: From the start of index procedure to end of index procedure

    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 is considered to have failed if it did not meet the requirements of the definition for clinical device success.

  2. Acute Success: Procedural success (patient based analysis)

    Time frame: From the start of index procedure to end of index procedure

    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.

  3. Death (Cardiovascular, Non-Cardiovascular)

    Time frame: 1 year

  4. Death (Cardiovascular, Non-Cardiovascular)

    Time frame: 3 year

  5. Myocardial Infarction (MI)

    Time frame: 1 year

    Attributable to Q-wave MI (QMI), non-Q wave MI (NQMI), target vessel (TV), non-target vessel (NTV)

  6. MI

    Time frame: 3 year

    Attributable to Q-wave MI (QMI), non-Q wave MI (NQMI), target vessel (TV), non-target vessel (NTV)

  7. Target Lesion Revascularization (TLR)

    Time frame: 1 year

    all TLR

  8. TLR

    Time frame: 3 year

    all TLR

  9. TLR

    Time frame: 1 year

    clinically indicated (ID-TLR)

  10. TLR

    Time frame: 3 year

    ID-TLR

  11. Target Vessel Revascularization (TVR)

    Time frame: 1 year

    all TVR

  12. TVR

    Time frame: 3 year

    all TVR

  13. TVR

    Time frame: 1 year

    clinically indicated (ID-TVR)

  14. TVR

    Time frame: 3 year

    ID-TVR

  15. Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint)

    Time frame: 1 year

  16. Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint)

    Time frame: 3 year

  17. Cardiac Death/All MI/ID-TLR (MACE)

    Time frame: 1 year

  18. Cardiac Death/All MI/ID-TLR (MACE)

    Time frame: 3 year

  19. Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF))

    Time frame: 1 year

  20. Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF))

    Time frame: 3 year

  21. Scaffold/Stent Thrombosis

    Time frame: 1 year

    acute, sub-acute, late and very late

  22. Scaffold/Stent Thrombosis

    Time frame: 1 year

    Definite, Probable

  23. Scaffold/Stent Thrombosis

    Time frame: 3 year

    acute, sub-acute, late and very late

  24. Scaffold/Stent Thrombosis

    Time frame: 3 year

    Definite, Probable

Other outcomes

  1. Acute Procedural Analyses (all patients)

    Time frame: During the implantation procedure

    • Access site (femoral, brachial, radial)
    • Lesion preparation (Lesion 1, 2, 3, etc.)
    • Balloon pre-dilatation (yes - Max balloon size/Max balloon pressure, Cutting balloon yes/no, Other yes/no)
    • Techniques used to adequately prepare the lesion (de-calcification techniques (Rotablator yes/no, Other yes/no))
    • Treatment parameters
    • CASS numbers
    • No. of scaffolds per analyzable lesion (Lesion 1, 2, 3, etc.)
    • Scaffold length (Lesion 1, Lesion 2, Lesion 3, etc.)
    • Lesion length (Lesion 1, Lesion 2, Lesion 3, etc.)
    • Bailout / bailout device (if bailout required)
    • Post-treatment of lesion?
    • Balloon post-dilatation (no, yes - Max balloon diameter/Max balloon pressures/balloon length)
    • Jailed side-branch (no, yes). If yes, treatment of jailed sidebranch? (no, yes)

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

A Post-market Registry of Patients With de Novo Lesions in Previously Untreated Vessels Treated With Absorb BVS

Acronym: ABSORB UK

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Nov 6, 2013
Registry last updated
Dec 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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