Trial Outcomes & Findings for Clinical Investigation for Everolimus Drug Eluting Stent (NCT NCT06769217)
NCT ID: NCT06769217
Last Updated: 2026-03-11
Results Overview
The primary endpoint of the study is defined as Major Adverse Cardiac Events (MACE) at 30 days. Note: MACE rate is defined as the incidence of the combined clinical endpoint: Composite of Death (Cardiac death as well as Non-Cardiac), Myocardial Infarction (Q-wave and non-Q-wave), Emergency Coronary Artery Bypass Graft Surgery, clinically justified TLR within 30 days following index procedure.
COMPLETED
PHASE4
888 participants
30 days
2026-03-11
Participant Flow
Participants were recruited based on the inclusion criteria
888 enrolled Participants.
Unit of analysis: Lesions
Participant milestones
| Measure |
Single Arm
Its a single arm multicenter registry to investigate safety and efficacy of product by clinical follow up at one month and 12 month
Everolimus Drug Eluting Coronary Stent: The Drug Eluting Coronary stent is indicated for the treatment of de novo coronary artery lesions in patients with symptomatic ischemic heart disease.
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|---|---|
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Overall Study
STARTED
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888 956
|
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Overall Study
30 Days Follow Up
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888 956
|
|
Overall Study
COMPLETED
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888 956
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Investigation for Everolimus Drug Eluting Stent
Baseline characteristics by cohort
| Measure |
Single Arm
n=956 lesions
Its a single arm multicenter registry to investigate safety and efficacy of product by clinical follow up at one month and 12 month
Everolimus Drug Eluting Coronary Stent: The Drug Eluting Coronary stent is indicated for the treatment of de novo coronary artery lesions in patients with symptomatic ischemic heart disease.
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|---|---|
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Age, Continuous
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58.91 Years
STANDARD_DEVIATION 10.29 • n=888 Participants
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Sex: Female, Male
Female
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250 Participants
n=888 Participants
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Sex: Female, Male
Male
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638 Participants
n=888 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: subjects with symptomatic coronary artery disease
The primary endpoint of the study is defined as Major Adverse Cardiac Events (MACE) at 30 days. Note: MACE rate is defined as the incidence of the combined clinical endpoint: Composite of Death (Cardiac death as well as Non-Cardiac), Myocardial Infarction (Q-wave and non-Q-wave), Emergency Coronary Artery Bypass Graft Surgery, clinically justified TLR within 30 days following index procedure.
Outcome measures
| Measure |
Single Arm
n=956 lesions
Its a single arm multicenter registry to investigate safety and efficacy of product by clinical follow up at one month and 12 month
Drug Eluting Coronary Stent: The Drug Eluting Coronary stent is indicated for the treatment of de novo coronary artery lesions in patients with symptomatic ischemic heart disease.
|
|---|---|
|
888 Number of Participants With Major Adverse Cardiac Events (MACE) at 30 Days
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0 participants
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SECONDARY outcome
Timeframe: 12 monthPopulation: subjects with symptomatic coronary artery disease
Angiographic success 100% Procedural success was demonstrated by restored TIMI grade 3 flow 97.07% Early device-related serious adverse events 0
Outcome measures
| Measure |
Single Arm
n=881 lesions
Its a single arm multicenter registry to investigate safety and efficacy of product by clinical follow up at one month and 12 month
Drug Eluting Coronary Stent: The Drug Eluting Coronary stent is indicated for the treatment of de novo coronary artery lesions in patients with symptomatic ischemic heart disease.
|
|---|---|
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• MACE (%) Until 12 Months • Device-related SAEs Until 12 Months
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881 participants
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Adverse Events
Single Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place