Coronary Artery Disease Clinical Trial
Official title:
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
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.
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Observational Model: Cohort, Time Perspective: Prospective
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