ABSORB UK: 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
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
ABSORB UK registry is a prospective, single arm, post-market registry designed to:
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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).
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Absorb BVS Subjects receiving Absorb BVS |
Device: Absorb 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].
|
Outcome Measures
Primary Outcome Measures
- 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]
- Death (Cardiovascular, Non-Cardiovascular) [3 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
- TLR [1 year]
clinically indicated (ID-TLR)
- TLR [3 year]
ID-TLR
- Target Vessel Revascularization (TVR) [1 year]
all TVR
- TVR [3 year]
all TVR
- TVR [1 year]
clinically indicated (ID-TVR)
- TVR [3 year]
ID-TVR
- Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint) [1 year]
- Cardiac Death/TV-MI/ID-TLR (Target Lesion Failure (TLF)) (Device-oriented endpoint) [3 year]
- Cardiac Death/All MI/ID-TLR (MACE) [1 year]
- Cardiac Death/All MI/ID-TLR (MACE) [3 year]
- Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)) [1 year]
- Cardiac Death/All MI/ID-TVR (Target Vessel Failure (TVF)) [3 year]
- Scaffold/Stent Thrombosis [1 year]
acute, sub-acute, late and very late
- Scaffold/Stent Thrombosis [1 year]
Definite, Probable
- Scaffold/Stent Thrombosis [3 year]
acute, sub-acute, late and very late
- Scaffold/Stent Thrombosis [3 year]
Definite, Probable
Other Outcome Measures
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
The inclusion criteria must follow the most recent IFU which may include but are not limited to the following:
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Patient must be at least 18 years of age at the time of signing the Informed Consent Form
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Patient is to be treated for de novo lesions located in previously untreated vessels.
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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:
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Inability to obtain a signed informed consent from potential patient.
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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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lister Hospital | Stevenage | Hertfordshire | United Kingdom | |
| 2 | Basildon Hospital | Basildon | United Kingdom | ||
| 3 | Royal Victoria Hospital | Belfast | United Kingdom | ||
| 4 | Glan Clwyd District General Hospital | Bodelwyddan | United Kingdom | ||
| 5 | Royal Bournmouth Hospital | Bournemouth | United Kingdom | ||
| 6 | Sussex Cardiac Centre | Brighton | United Kingdom | ||
| 7 | Bristol Heart Institute | Bristol | United Kingdom | ||
| 8 | Papworth Hospital | Cambridge | United Kingdom | ||
| 9 | Royal Infirmary of Edinburgh | Edinburgh | United Kingdom | ||
| 10 | Frimley Park Hospital | Frimley | United Kingdom | ||
| 11 | Golden Jubilee National Hospital | Glasgow | United Kingdom | ||
| 12 | Leeds General Infirmary | Leeds | United Kingdom | ||
| 13 | Glenfield Hospital | Leicester | United Kingdom | ||
| 14 | Barts Heart Centre | London | United Kingdom | ||
| 15 | Kings College Hospital | London | United Kingdom | ||
| 16 | Northwick Park Hospital | London | United Kingdom | ||
| 17 | Royal Brompton Hospital | London | United Kingdom | ||
| 18 | Manchester Royal Infirmary | Manchester | United Kingdom | ||
| 19 | James Cook University Hospital | Middlesbrough | United Kingdom | ||
| 20 | The Freeman Hospital | Newcastle | United Kingdom | ||
| 21 | Norfolk & Norwich University Hospital | Norwich | United Kingdom | ||
| 22 | John Radcliffe Hospital | Oxford | United Kingdom | ||
| 23 | Queen Alexandra Hospital | Portsmouth | United Kingdom | ||
| 24 | Southampton General Hospital | Southampton | United Kingdom |
Sponsors and Collaborators
- Abbott Medical Devices
Investigators
- Principal Investigator: Andreas Baumbach, Bristol Heart institute
- Study Director: Susan Veldhof, Clinical Science
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 13-304