Introduction to Device Trials

In device trials, antithrombotic regimens in patients receiving peripheral vascular interventions have not been clearly reported on.

Standardization of the most critical clinical and angiographic endpoints enables interpretability and comparability of different device trials.

Conclusion In light of documented adverse neurologic effects, the frequency of intrathrombus polymer particulates indicates the need for consensus testing methods and large-scale long-term prospective clinical device trials, with inclusion of relevant endpoints to better assess biomaterial and device risks to patients.

Methods We evaluated current ACC/AHA/HFSA and ESC HF guidelines and the GDMT definition in 8 HF drug and device trials.

Interventional, drug and device trials were not significantly more likely to be completed.

ResultsOur sample consisted of 18 device trials initiated between January 2012 and January 2016.

As the field of retinal prostheses advances, volunteers are required for device trials, and optimal participant recruitment is vital for intervention success.

Conclusions- Noninferiority margins used in EVT device trials have regularly exceeded the MCIDs determined by stroke experts, as well as margins used for cardiac devices.

Conclusion: The overall reporting quality in randomized controlled trials of therapeutic medical device trials is suboptimal, particularly in terms of items regarding surgeons and hospitals.

Non-inferiority trials are commonly seen in medical device trials.

Setting Being aware of the pitfalls associated with previous medical device trials, we developed a training programme to improve CPFA use (especially clotting problems).

The authors conducted a systematic review of high-risk trials, defined as randomized medication or device trials that specifically recruited individuals with psychotic disorders, to understand the use of capacity to consent assessment and their reporting.

This focus on vessel patency in clinical practice parallels the design of peripheral device trials, in which vessel patency is almost always the primary endpoint.