SPIRIT V: Post-marketing Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in Europe (SPIRIT V)
|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|
|Primary Completion Date :||February 2008|
|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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402272
Show 93 Study Locations
|Principal Investigator:||Eberhard Grube, MD||The Heart Center, Siegburg, Germany|
|Principal Investigator:||Upendra Kaul, MD||Fortis Hospital, New Delhi, India|