The X-Pand Registry is intended to facilitate analysis of acute \& long-term safety as well as treatment outcomes with DESolve in patients with CAD.
The Xpand Registry is a single-arm, multi-center, clinical Follow up study of patients with significant coronary stenosis who are treated with a commercially available DESolve Scaffold. The Registry is an observational study. The patients should be treated according to the current DESolve IFU, professional societies guidelines \& internal hospital guidelines.
Study Type
OBSERVATIONAL
Enrollment
154
Percutaneous Coronary Artery Intervention with a DESolve bioresorbable coronary scaffold
Kerckhoff-Klinik
Bad Nauheim, Germany
Universitätsklinikum Giessen
Giessen, Germany
GPR Klinikum Rüsselsheim
Rüsselsheim am Main, Germany
Krankenhaus der Barmherzigen Brüder
Trier, Germany
TLF (Target Lesion Failure)
TLF is defined as: cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization (TLR)
Time frame: 12 months
Death
All cause mortality
Time frame: 12 months
MI
Myocardial Infarction
Time frame: 12 months
CABG
Emergency bypass surgery (CABG)
Time frame: 12 months
CD-TVR
Clinically-driven revascularization of the target vessel (Target Vessel Revascularization, TVR) using percutaneous or surgical methods (CABG)
Time frame: 12 months
Thrombosis
Thrombosis: The ARC stent thrombosis criteria are applied
Time frame: 12 months
Device Success
Successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis \< 50% by QCA (by visual estimation if QCA is unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout subjects will be included as device success only if the above criteria for clinical device success are met
Time frame: day of treatment procedure
Procedure Success
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Successful delivery and deployment of the DESolve scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of \< 50% by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure.
Time frame: 30 days
MACE
MACE is defined as: cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization (TLR)
Time frame: 3 years