Coronary Disease, Coronary Artery Disease, Coronary Restenosis
Conditions
Keywords
Bioabsorbable, Coronary Stent, Everolimus, drug eluting stents, stents, angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease, myocardial ischemia, coronary artery stenosis, CAD, CAOD
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAbsorb BVS
The Absorb BVS System is a bioresorbable poly(L-lactide) (PLLA) scaffold with a drug and bioresorbable polymer coating \[formulation of everolimus in a bioresorbable poly(D,L-lactide) (PDLLA) coating\].
Sponsors
Abbott Medical Devices
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scaffold/Stent Thrombosis | 1 year | acute, sub-acute, late and very late |
| Acute Success: Device success (lesion based analysis) | 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. |
| Acute Success: Procedural success (patient based analysis) | 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. |
| Death (Cardiovascular, Non-Cardiovascular) | 1 year | — |
| Myocardial Infarction (MI) | 1 year | Attributable to Q-wave MI (QMI), non-Q wave MI (NQMI), target vessel (TV), non-target vessel (NTV) |
| MI | 3 year | Attributable to Q-wave MI (QMI), non-Q wave MI (NQMI), target vessel (TV), non-target vessel (NTV) |
| Target Lesion Revascularization (TLR) | 1 year | all TLR |
| TLR | 3 year | all TLR |
| Target Vessel Revascularization (TVR) | 1 year | all TVR |
| TVR | 3 year | all TVR |
| Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint) | 1 year | — |
| Cardiac Death/All MI/ID-TLR (MACE) | 1 year | — |
| Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)) | 1 year | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acute Procedural Analyses (all patients) | 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) |
Countries
United Kingdom
Outcome results
None listed