ABSORB Post-Approval Clinical Study
Withdrawn before enrolling · Not applicable
Conditions studied: Ischemic Heart Disease
In brief
The ABSORB Post-Approval Clinical Study is a prospective, open-label, multi-center, single-arm, non-randomized trial to evaluate the safety of the use of ABSORB in a real-world setting following commercial physician training'and to observe the effectiveness of commercial physician training on appropriate vessel sizing.
Key facts
- Study ID
- NCT02943616
- Run by
- Abbott Medical Devices
- People needed
- 0
- Starts
- 2017-08-01
- Expected to finish
- 2021-01-01
- Last updated by the study team
- 2018-01-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- The subject agrees and signs the Institutional Review Board (IRB) approved informed consent form
- The subject receives an Absorb
You may not qualify if…
- Subject is a member of a vulnerable population.
- Vulnerable population: Defined as subject whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples of populations which may contain vulnerable subjects include: Individuals with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished persons, subjects in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, and those incapable of giving informed consent. Other vulnerable subjects include, for example, members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the sponsor, members of the armed forces, and persons kept in detention
Where it is running
- Tallahassee Memorial Hospital — Tallahassee, Florida, United States
- Franciscan St. Francis Health — Indianapolis, Indiana, United States
- Baptist Health Louisville — Louisville, Kentucky, United States
- Englewood Hospital and Medical Center — Englewood, New Jersey, United States
- Turkey Creek Medical Center — Knoxville, Tennessee, United States
Full record on ClinicalTrials.gov
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