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

N/ACompletedNCT01977534

Abbott Medical Devices1,005 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,005

Conditions

Coronary Disease Coronary Artery Disease Coronary Restenosis

Interventions

Absorb BVSDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (24)

Lister Hospital

Stevenage, Hertfordshire, United Kingdom

Outcomes

Primary Outcomes

Acute Success: Device success (lesion based analysis)

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.

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

Acute Success: Procedural success (patient based analysis)

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.

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

Death (Cardiovascular, Non-Cardiovascular)

Time frame: 1 year

Death (Cardiovascular, Non-Cardiovascular)

Time frame: 3 year

Myocardial Infarction (MI)

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

Time frame: 1 year

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

Time frame: 3 year

Target Lesion Revascularization (TLR)

all TLR

Time frame: 1 year

TLR

all TLR

Data from ClinicalTrials.gov

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