Coronary Artery Disease, Coronary Disease, Coronary Restenosis
Conditions
Keywords
drug eluting stents, stents, Angioplasty, coronary artery disease, total coronary occlusion, coronary artery restenosis, stent thrombosis, vascular disease, myocardial ischemia, coronary artery stenosis
Brief summary
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.
Detailed description
The SPIRIT V Clinical Evaluation consists of two concurrent studies,the Diabetic Sub-Study and the Registry. 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). 2,700 patients will be enrolled in the SPIRIT V Registry. The long term safety and efficacy of the XIENCE V EECSS have been demonstrated in the SPIRIT FIRST trial up to 5 years, the SPIRIT II trial up to 4 years, and in the SPIRIT III Randomized Control Trial (RCT) up to 3 years. In addition, these pre-approval studies have shown low rates of Target Vessel Failure and Major Adverse Cardiac Events (MACE) that were observed to plateau or gradually decline after about 1 year and were consistently lower than the comparator arm of each study. This benefit in MACE is sustained for up to 5 years and is also independent of the first year results. The post approval SPIRIT V study demonstrated that the use of the XIENCE EECSS in complex lesions in a real-world population resulted in 1 year MACE, Stent Thrombosis and Target Lesion Revascularization rates that are comparable to those of the previously mentioned pre-approval studies which included patients with more restricted inclusion / exclusion criteria. Therefore, based on existing data from these trials, Abbott Vascular has decided to discontinue further follow up in the SPIRIT V Registry study after 2 years.
Interventions
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Sponsors
Abbott Medical Devices
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least 18 years * able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the XIENCE V® EECSS and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site * evidence of myocardial ischemia * acceptable candidate for coronary artery bypass graft (CABG) surgery * undergo all CIP-required follow-up examinations * artery morphology and disease is suitable to be optimally treated with a maximum of 4 planned XIENCE V® EESCC * target lesions must be de novo lesions * 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 estimate
Exclusion criteria
Patient is already participating in another device or drug study or has completed the follow-up phase of another study within the last 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SPIRIT V Registry: Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) . | at 30 days |
Secondary
| Measure | Time frame |
|---|---|
| SPIRIT V Registry: Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and TLR | at 30 days, 1 and 2 years |
| SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and TVR | at 30 days, 1 and 2 years |
| SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and any Revascularization(TLR/TVR/non TVR) | at 30 days, 1 and 2 years |
| SPIRIT V Registry: Adjudicated Revascularizations (TLR/TVR/any Revascularization) | at 30 days, 1 and 2 years |
| SPIRIT V Registry: Acute Success (Clinical Procedure Success) | Acute |
| SPIRIT V Registry: Adjudicated Stent Thrombosis (Confirmed/definite, Probable, Possible) | at 30 days, 1 and 2 years |
| SPIRIT V Registry: Acute Success (Clinical Device Success) | Acute |
Countries
Austria, Belgium, Canada, China, Czechia, France, Germany, Greece, India, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom
Outcome results
None listed