Clinical trial NCT01097434: Test Safety of Biodegradable and Permanent Limus-Eluting Stents Assessed by Optical Coherence Tomography
Official title: Randomized Comparison of Limus-Eluting Stents With Biodegradable or Permanent Polymer Coating Regarding Stent Coverage Assessed by Optical Coherence Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Heart Disease
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2010-04-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to assess the superiority of the biodegradable polymer based limus-eluting stent (Nobori®) compared with the permanent polymer based everolimus-eluting stent (XIENCE V®) regarding absolute percentage of uncovered stent strut segments.

Detailed description: The mid-term efficacy of drug-eluting stents has been well-established, but there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, particularly after discontinuation of thienopyridine therapy, as well as of delayed onset of restenosis or catch-up phenomenon with permanent polymer-based DES. The extent of strut coverage with reduction of exposed thrombogenic material has been shown to be associated with the inflammatory reaction grade and with the incidence of stent thrombosis. The optical coherence tomography (OCT) is an intravascular imaging modality based on light. The principle is similar to intravascular ultrasound, but due to the much shorter wave length of light, it offers a much better resolution up to 10µm, enabling the exact determination of strut coverage, neointimal thickness, vessel size, presence of dissections, and even the presence of inflammation.

Eligibility criteria: Inclusion Criteria:

* Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% stenosis located in native coronary vessels
* Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
* In women with childbearing potential a negative pregnancy test is mandatory

Exclusion Criteria:

* Lesion length \>16mm requiring a stent length \>18mm
* Target lesion located in the left main trunk
* In-stent restenosis
* Acute myocardial infarction
* Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance
* Known allergy to the study medications: rapamycin, everolimus, biolimus, stainless steel or cobalt chrome
* Inability to take dual antiplatelet therapy for at least 6 months
* Pregnancy (present, suspected or planned) or positive pregnancy test
* Previous enrollment in this trial
* Patient's inability to fully cooperate with the study protocol

Primary outcomes:
measure: Percentage of uncovered stent strut segments assessed by OCT
timeFrame: 6-8 months
Secondary outcomes:
measure: Percentage of malposed stent strut segments assessed by OCT
timeFrame: 6-8 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Julinda Mehilli, MD
role: PRINCIPAL_INVESTIGATOR
References: