The purpose of this Clinical Evaluation is a continuation in the assessment of the performance of the XIENCE* V Everolimus Eluting Coronary Stent System (XIENCE* V EECSS) in the treatment of patients with de novo coronary artery lesions.
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the SPIRIT V Diabetic Study is in-stent Late Loss (LL)
at 270 days.
The primary endpoint of the SPIRIT V Registry is Adjudicated Composite rate of
All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR)
at 30 days.
Secondary outcome
SPIRIT V Diabetic Study:
Acute Success (Clinical Device Success and Clinical Procedure Success);
Adjudicated Stent Thrombosis at 30 days, 240 days, 1, 2, 3, 4 and 5
years:(Confirmed/definite, Probable, Possible)
In-segment, proximal and distal Late Loss at 270 days: In-stent and in-segment
Angiographic Binary Restenosis rates at 270 days; In-stent and in-segment
percent Diameter Stenosis at 270 days; Adjudicated Target Lesion
Revascularization (TLR) rate at 30 days, 240 days, 1, 2, 3, 4 and 5 years (both
Clinical-indicated and not clinical-indicated); Adjudicated Composite rate of
Cardiac Death, Myocardial Infarction (MI) and Clinical-indicated Target Lesion;
Revascularization (CI-TLR) at 30 days, 240 days, 1, 2, 3, 4 and 5 years;
Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target
Vessel Revascularization (TVR) at 30 days, 240 days, 1, 2, 3, 4 and 5 years.
The primary endpoint of the SPIRIT V Registry is Adjudicated Composite rate of
All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR)
at 30 days.
Spirit V Registry:
Acute Success (Clinical Device Success and Clinical Procedure Success);
Adjudicated Stent Thrombosis at 30 days, and at 1 and 2 years
(Confirmed/definite, Probable, Possible)
Adjudicated TLR at 30 days, 1 and 2 years; Adjudicated Composite rate of
Cardiac Death, MI and CI-TLR at 30 days, 1 and 2 years; Adjudicated Composite
rate of All Death, MI and TVR at 1 and 2 years
Background summary
Stenting of de novo lesions in native coronary arteries has been shown to be a
safe and effective treatment of occlusion due to atherosclerosisis. However,
many interventional cardiologists believe that restenosis following stenting is
the most significant and pressing problem in the field of interventional
cardiology today.
Various therapies intended to reduce the rate of restenosis have been tested in
clinical studies and in clinical practice. These methods include the use of
various sources of radiation as well as the local delivery or application of an
anti-proliferative drug to the lesion site. The current research focus is
aimed at assessing the efficacy and safety of implanting coronary stents coated
with various doses or formulations of drugs to reduce neointimal
proliferation.
The fact that everolimus has shown safety and efficacy in feasibility studies
with widely varying stent platforms, coating systems and release profiles,
provides evidence of safety for further evaluation in larger studies.
Spirit V consists of two parts, the Spirit V Diabetic study and the Spirit V
Registry.
The data gathered in the Spirit V Diabetic study will allow further and more
specific investigation of the diabetic population - both insulin dependent and
non-insulin dependent - with a higher incidence of more complex lesions and a
higher risk of developing cardiac events. This clinical evaluation will
therefore provide a significant complement to the performance data obtained
from the randomized clinical trials.
In the Spirit V Registry more complex and challenging lesions will be studied,
compared to Spirit First and Spirit II, in a real-life treatment setting
according to criteria as described in the Instructions for Use (IFU) (Appendix
B).
Study objective
The purpose of this Clinical Evaluation is a continuation in the assessment of
the performance of the XIENCE* V Everolimus Eluting Coronary Stent System
(XIENCE* V EECSS) in the treatment of patients with de novo coronary artery
lesions.
Study design
The SPIRIT V Clinical Evaluation consists of two concurrent studies, the
Diabetic Study and the Registry. The SPIRIT V Diabetic Study is a prospective,
randomized, active-controlled, single blind, parallel two-arm multi-center
study comparing the XIENCE* V EECSS to the TAXUS® Liberté* in the treatment of
diabetic patients with coronary artery lesions who will fulfill the eligibility
criteria. The SPIRIT V Registry is a prospective, single arm, multi-center
registry evaluating performance of the XIENCE* V EECSS in real-world use, per
its Instruction For Use (IFU).
The study will be conducted in up to 150 study centers outside of the United
States. Approximately 3,000 patients will be enrolled in the study:
300 patients will be randomized (2:1) in the Spirit V Diabetic study against
the TAXUS® Liberté* Coronary Stent System. These patients will be recruited in
30 selected sites only.
2700 patients will be enrolled in the Spirit V Registry.
Intervention
The treatment strategy for all patients enrolled in the Spirit V Diabetic study
is as follows:
Patients may receive up to 4 planned stents, depending on the number of vessels
treated and their respective lesion lengths. Maximum of one de novo, native
target lesion per major epicardial vessel or side branch (no prior stent
implant, no prior brachytherapy)
The treatment strategy for all patients enrolled in the Spirit V Registry is as
follows:
Patients may receive up to 4 planned XIENCE V* EECSS stents depending on the
number of vessels treated and their respective lesion lengths
Study burden and risks
Potential Risks: Risks from Cardiac Catheterization, Stenting and Percutaneous
Transcatheter Coronary Angioplasty
Associated Risks of Everolimus: Everolimus is extensively metabolized by the
cytochrome P4503A4 (CYP3A4) in the gut wall and liver and is a substrate for
the countertransporter P-glycoprotein. Therefore, absorption and subsequent
elimination of everolimus may be influenced by drugs that affect these
pathways. Everolimus has also been shown to reduce the clearance of some
prescription medications when it was administered orally along with
cyclosporine (CsA). Formal drug interaction studies have not been performed
with XIENCE* V Everolimus Eluting Coronary Stent System. Therefore, due
consideration should be given to the potential for both systemic and local drug
interactions in the vessel wall when deciding to place the XIENCE* V Everolimus
Eluting Coronary Stent in a subject taking a drug with known interaction with
everolimus.
Park lane, Culliganlaan 2B
B-1831 Diegem
Belgium
Park lane, Culliganlaan 2B
B-1831 Diegem
Belgium
Listed location countries
Age
Inclusion criteria
Maximum of one, de novo, target lesion per native major epicardial vessel or side branch (no prior stent implant, no prior brachytherapy
Target vessel reference diameter must be between 2.5 mm and 4.0 mm by visual estimate
Target lesion <28 mm in length by visual estimation
Target lesion must be in a major artery or branch with a visually estimated stenosis of >50% and <100% and a TIMI flow>1
Spirit V Registry: According tot he instructions for Use (IFU)
Exclusion criteria
Patient has had a known diagnosis of acute myocardial infarction within 72 hours preceding the index procedure
Patient has current unstable arrhythmias
Patient has a known left ventricular ejection fraction <30%
Spirit V Registry: According to the instructions for Use (IFU)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL13612.060.06 |