What question did this study set out to answer?

Define prospective surveillance and reporting guidelines for the assessment of metallic stent integrity in clinical trials targeting superficial femoral artery atherosclerosis.

June 8, 2007Catheterization and Cardiovascular Interventions

Standardized evaluation and reporting of stent fractures in clinical trials of noncoronary devices

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Authors

MJMichael R. JaffVascular / Pulmonary Vascular MDMichael D. DakeInterventional / Structural Cardiology JPJeffrey Pompa

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Implication

Randomized trial protocol defines standardized surveillance for metallic stent fractures in peripheral arterial disease, highlighting the need for uniform device safety evaluations.

Key Points

Define prospective surveillance and reporting guidelines for the assessment of metallic stent integrity in clinical trials targeting superficial femoral artery atherosclerosis.
Designed within the framework of the Zilver-PTX prospective multicenter randomized trial comparing bare metal versus drug-eluting nitinol stents for superficial femoral artery disease.
Identified existing gaps in standardized surveillance and established parameters for radiographic imaging, positioning, intervals, and grading schemes.
Established standard specifications for radiographic equipment, anatomical imaging locations, and precise limb and image intensifier positioning.
Developed a standardized fracture grading scheme and uniform image analysis protocols to reliably detect, classify, and report stent fracture and disarticulation.

Cite This Study

Jaff et al. (2007) studied this question.

synapsesocial.com/papers/6a83bbcaf4298de60b3c27ed https://doi.org/10.1002/ccd.21240

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Implication

Randomized trial protocol defines standardized surveillance for metallic stent fractures in peripheral arterial disease, highlighting the need for uniform device safety evaluations.

Standardized evaluation and reporting of stent fractures in clinical trials of noncoronary devices

Discussion

Member takes

Implication

Key Points

Cite This Study

Standardized evaluation and reporting of stent fractures in clinical trials of noncoronary devices

Discussion

Member takes

Implication

Key Points

Cite This Study

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