Trial Outcomes & Findings for NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions (NCT NCT00231283)

Results Overview

Procedure Success is defined as the final residual diameter stenosis \< 50 percent by Quantitative Coronary Angiography (QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

100 participants

Primary outcome timeframe

From post-procedure up to hospital discharge

Results posted on

2010-04-20

Participant Flow

First patient enrolled was Apr 2004 and last patient enrolled was Jul 2004.

Participant milestones

Participant milestones
Measure	CYPHER NxT Stent on the BX SONIC OTW SDS CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
Overall Study STARTED	100
Overall Study COMPLETED	95
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CYPHER NxT Stent on the BX SONIC OTW SDS n=100 Participants CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=5 Participants
Age, Categorical >=65 years	51 Participants n=5 Participants
Age Continuous	64.39 years STANDARD_DEVIATION 10.80 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	68 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants
Patients with Diabetes Mellitus With Diabetes Mellitus	25 participants n=5 Participants
Patients with Diabetes Mellitus Without Diabetes Mellitus	75 participants n=5 Participants

PRIMARY outcome

Timeframe: From post-procedure up to hospital discharge

Population: Patients who were followed up to hospital discharge

Procedure Success is defined as the final residual diameter stenosis \< 50 percent by Quantitative Coronary Angiography (QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion

Outcome measures

Outcome measures
Measure	CYPHER NxT Stent on the BX SONIC OTW SDS n=100 Participants CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
Percentage of Participants Who Achieved Procedure Success From Post-procedure to Hospital Discharge	97 Percentage of Participants

SECONDARY outcome

Timeframe: From post-procedure up to 30 days

Population: Patients who had 30 days clinical follow-up.

Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).

Outcome measures

Outcome measures
Measure	CYPHER NxT Stent on the BX SONIC OTW SDS n=99 Participants CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 30 Days Later	3.0 Percentage of Participants

SECONDARY outcome

Timeframe: From post-procedure up to hospital discharge

Population: Patients who were followed up to hospital discharge

Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).

Outcome measures

Outcome measures
Measure	CYPHER NxT Stent on the BX SONIC OTW SDS n=100 Participants CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to Hospital Discharge	3.0 Percentage of participants

SECONDARY outcome

Timeframe: From post-procedure up to 12 months

Population: Patients who had at least 330 days clinical follow-up.

Major Adverse Cardiac Events (MACE) consists of death, Myocardial Infarction (Q-wave and Non Q-wave), emergent Coronary Artery Bypass Graft (CABG) or Target Lesion Revascularization (TLR).

Outcome measures

Outcome measures
Measure	CYPHER NxT Stent on the BX SONIC OTW SDS n=96 Participants CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
Percentage of Participants Who Experienced Any Major Adverse Cardiac Events From Post-procedure to 12 Months Later	10.4 Percentage of participants

Adverse Events

CYPHER NxT Stent on the BX SONIC OTW SDS

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CYPHER NxT Stent on the BX SONIC OTW SDS n=96 participants at risk；n=95 participants at risk CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
Vascular disorders Death	1.1% 1/95 • Number of events 1

Other adverse events

Other adverse events
Measure	CYPHER NxT Stent on the BX SONIC OTW SDS n=96 participants at risk；n=95 participants at risk CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
Vascular disorders Myocardial Infarction (Q wave or Non-Q wave)	3.1% 3/96 • Number of events 3
Vascular disorders Emergent CABG	1.0% 1/96 • Number of events 1
Vascular disorders Target Lesion Revascularization	6.3% 6/95 • Number of events 6
Vascular disorders Target Vessel Revascularization not involving the Target Lesion	1.1% 1/95 • Number of events 1
Vascular disorders Target Vessel Revascularization	7.4% 7/95 • Number of events 7
Vascular disorders Target Vessel Failure	10.4% 10/96 • Number of events 10
Vascular disorders Major Vascular Complications	1.1% 1/95 • Number of events 1
Vascular disorders Ischemic Complications	1.0% 1/96 • Number of events 1

Additional Information

Sidney Cohen, MD PhD, Vice President

Cordis

Phone: 650 614-2726

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60