Bioresorbable Scaffolds Clinical Trial
The biodegradable ABSORB scaffold is characterized by a greater strut thickness, but it has a greater flexibility compared to the XIENCE stent. Due to its fragility the inflating pressure of the ABSORB scaffold is limited and suitable lesions have to be well prepared. This study assesses the incidence of malapposed stent-struts, and the frequency of stent-underexpansion and edge dissection after ABSORB implantation compared to the XIENCE stent.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria for implanting an Absorb scaffold: - age < 55 years OR - lesion length > 24mm OR - multiple lesions to be treated |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medical University of Vienna | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Rudolf Berger |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | adverse post-stenting results | Malapposition, underexpansion and edge dissections assessed with Optical Coherence Tomography (OCT) | 1 year | No |