Efficacy and Safety of Xience in Coronary arEry Disease aLL-comers After stENTing Using the PRIME Platform (EXCELLENT-PRIME Registry)

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01605721
• Collaborator: Abbott (Industry)
• Enrollment: 2,000
• Location: 1
• Arm: 1
• Duration (Months): 47
• Patients Per Site Per Month: 42.5

Study Details

Study Description

Brief Summary

Objectives:

1. To evaluate the safety and long-term effectiveness of coronary stenting with the XIENCE PRIMETM in a cohort of "real world" patients and lesion subsets.

2. To determine clinical device and procedural success during commercial use of XIENCE PRIMETM coronary stent

Study population : Approximately consecutive 2000 patients treated with XIENCE PRIMETM

Study period

• Patient enrollment: 2011.05 ~ 2012.04

• End of follow-up period: 2015. 02 (3 years of follow-up)

Primary endpoint

: Target Lesion Failure (TLF) rate at 12 months

Secondary endpoint:

• In-stent & In-segment Late Loss at 9 months

• Stent Thrombosis at 24 hours (acute), 30 days (subacute), 1 year (late), yearly up to 3 years (very late)

• Target Vessel Failure at 12 months (composite of cardiac death, MI, and TVR)

• Any death, cardiac death, MI, TLR, TVR at 30 days, 9months, 1 year, 3 years

• Composite rate of cardiac death and any MI up to 3 years

• Composite rate of all death and any MI up to 3 years

• Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization up to 3 years

• Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy up to 3 years

• Procedural success up to 1 day

• Angiographic success up to 1 day

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: XIENCE PRIMETM everolimus-eluting coronary stent	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 2000 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: May 1, 2011
• Anticipated Primary Completion Date: Apr 1, 2013
• Anticipated Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: XIENCE PRIMETM everolimus-eluting coronary stent	Device: XIENCE PRIMETM everolimus-eluting coronary stent; Active prospective registration of patients receiving the following stent : XIENCE PRIMETM

Outcome Measures

Primary Outcome Measures

1. Target Lesion Failure (TLF) rate at 12 months [12 months]

Secondary Outcome Measures

1. In-stent & In-segment Late Loss at 9 months [9 months]

2. Stent Thrombosis at 24 hours (acute), 30 days (subacute), 1 year (late), yearly up to 3 years (very late) [24 hours, 30 days, up to 3 years]

3. Any death, cardiac death, MI, TLR, TVR at 30 days, 9 months, 1 year, 3 years [30 days, 9 months, 1 year, up to 3 years]

4. Composite rate of cardiac death and any MI up to 3 years [up to 3 years]

5. Composite rate of all death and any MI up to 3 years [up to 3 years]

6. Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization up to 3 years [up to 3 years]

7. Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy up to 3 years [up to 3 years]

8. procedural success up to 1 day [1 day]

   failure : CK-MB of >3 times the upper limit of normal

9. angiographic success up to 1 day [1 day]

   success : a minimum stenosis diameter reduction to <20% in the presence of grade 3 TIMI flow (assessed by angiography)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

• The patient agrees to participate in this study by signing the informed consent form. Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.

Angiographic Inclusion Criteria

• There are no angiographic inclusion criteria for this study.

Exclusion criteria

• There are no exclusion criteria for this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Hospital
• Abbott

Investigators

• Study Chair: Hyo-Soo Kim, MD, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hyo-Soo Kim, MD PhD, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT01605721
• Other Study ID Numbers: H-1101-054-347
• First Posted: May 25, 2012
• Last Update Posted: May 25, 2012
• Last Verified: May 1, 2012

• Keywords provided by Hyo-Soo Kim, MD PhD, Seoul National University Hospital: Everolimus; XIENCE PRIME; Drug eluting stent
• Additional relevant MeSH terms: Coronary Artery Disease; Everolimus

Study Results

No Results Posted as of May 25, 2012