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slow enrollment due to change in worldwide scaffold usage
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| Name | Class |
|---|---|
| European Cardiovascular Research Center | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTCA - Desolve Scaffold | Patients with coronary artery stenosis who have been treated with a DESolve bioresorbable coronary scaffold |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTCA - Desolve Scaffold | Device | Percutaneous Coronary Artery Intervention with a DESolve bioresorbable coronary scaffold |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 months |
| Death | All cause mortality | 12 months |
| MI | Myocardial Infarction | 12 months |
| CABG | Emergency bypass surgery (CABG) | 12 months |
| CD-TVR | Clinically-driven revascularization of the target vessel (Target Vessel Revascularization, TVR) using percutaneous or surgical methods (CABG) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Thrombosis | Thrombosis: The ARC stent thrombosis criteria are applied | 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 |
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Inclusion Criteria:
Exclusion Criteria:
None
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patients who have received implants of one or more DESolve scaffold(s)
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| Name | Affiliation | Role |
|---|---|---|
| Jean Fajadet, Dr. | University Hospital of Toulouse | Principal Investigator |
| Holger Nef, Prof Dr. | University Hospital Giessen and Marburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kerckhoff-Klinik | Bad Nauheim | 61231 | Germany | |||
| Universitätsklinikum Giessen |
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| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| day of treatment procedure |
| Procedure Success | 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. | 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) | 3 years |
| Giessen |
| 35392 |
| Germany |
| GPR Klinikum Rüsselsheim | Rüsselsheim am Main | 65428 | Germany |
| Krankenhaus der Barmherzigen Brüder | Trier | 54292 | Germany |
| St. Antonius Ziekenhuis | Nieuwegein | 3430 | Netherlands |
| D014652 |
| Vascular Diseases |