SPIRIT V: Post-marketing Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in Europe (SPIRIT V)
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|ClinicalTrials.gov Identifier: NCT00402272|
Recruitment Status : Completed
First Posted : November 22, 2006
Last Update Posted : October 14, 2010
|Condition or disease||Intervention/treatment||Phase|
|Coronary Disease Coronary Artery Disease Coronary Restenosis||Device: XIENCE V® Everolimus Eluting Coronary Stent||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2700 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||June 2010|
XIENCE V® Everolimus Eluting Coronary Stent System
Device: XIENCE V® Everolimus Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease.
Other Name: XIENCE V® Everolimus Eluting Coronary Stent System
- SPIRIT V Registry: Adjudicated Composite rate of All Death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) . [ Time Frame: at 30 days ]
- SPIRIT V Registry: Acute Success (Clinical Procedure Success) [ Time Frame: Acute ]
- SPIRIT V Registry: Adjudicated Stent Thrombosis (Confirmed/definite, Probable, Possible) [ Time Frame: at 30 days, 1 and 2 years ]
- SPIRIT V Registry: Adjudicated Revascularizations (TLR/TVR/any Revascularization) [ Time Frame: at 30 days, 1 and 2 years ]
- SPIRIT V Registry: Adjudicated Composite rate of Cardiac Death, MI attributed to the target vessel and TLR [ Time Frame: at 30 days, 1 and 2 years ]
- SPIRIT V Registry: Adjudicated Composite rate of All Death, any MI and TVR [ Time Frame: 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) [ Time Frame: at 30 days, 1 and 2 years ]
- SPIRIT V Registry: Acute Success (Clinical Device Success) [ Time Frame: Acute ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402272
|Principal Investigator:||Eberhard Grube, MD||The Heart Center, Siegburg, Germany|
|Principal Investigator:||Upendra Kaul, MD||Fortis Hospital, New Delhi, India|