Late Acquired Stent Malaposition Clinical Trial
Official title:
Incidence and Predictors for Late Acquired Stent Malaposition of Drug-Eluting-Stents With Second-Generation Permanent and Biodegradable Polymer-Coatings - a Prospective, Randomized Comparison Using Optical Coherence Tomography
| Verified date | December 2013 |
| Source | Medical University of Vienna |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Austria: Agency for Health and Food Safety |
| Study type | Interventional |
The polymers releasing the drug of first-generation drug-eluting stents (DES) may induce allergic reactions and inflammation, resulting in late-acquired stent malaposition (LASM) with uncoverage of struts, and risk of stent thrombosis. The incidence and predictors of LASM in DES with newer-generation polymers designed to improve biocompatibility are unknown.
| Status | Completed |
| Enrollment | 69 |
| Est. completion date | August 2013 |
| Est. primary completion date | August 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients who underwent an elective treatment of a coronary lesion > 20mm with a DES Exclusion Criteria: - chronic renal failure (serum creatinine = 2.5mg/dl) - restenotic lesions |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medical University of Vienna | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Vienna |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of stent struts with late acquired malaposition | 1 year after stent implantation | Yes | |
| Secondary | number of stent struts with late acquired malaposition | 2 years after stent implantation | Yes |