Trial Outcomes & Findings for DELIVER Study: DELiverability of the Resolute Integrity Stent in All-Comer Vessels and Cross-OvER Stenting (NCT NCT01297257)
NCT ID: NCT01297257
Last Updated: 2014-03-06
Results Overview
The primary endpoint for this study is delivery success defined as complete passage of the Resolute Integrity stent across the target lesion with full expansion of the stent to the desired diameter at the desired location.
COMPLETED
7845 participants
stent implantation until hospital discharge (average 1-3 days)
2014-03-06
Participant Flow
Patients were enrolled at 163 centres in Europe, Asia, the Middle East, and Latin America from January 2011 to May 2012.
7845 subjects enrolled in this study. 22 Subjects removed from database, per center request. Reasons varied per center. 83 patients had very limited data available which resulted in the inability to be included in the analysis.
Participant milestones
| Measure |
Group 1 Resolute Integrity™ Stent Primary Stent
A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.
|
|---|---|
|
Overall Study
STARTED
|
7740
|
|
Overall Study
COMPLETED
|
7740
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DELIVER Study: DELiverability of the Resolute Integrity Stent in All-Comer Vessels and Cross-OvER Stenting
Baseline characteristics by cohort
| Measure |
Group 1 Resolute Integrity™ Stent Primary Stent
n=7740 Participants
A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4058 participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3662 participants
n=5 Participants
|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Gender
Female
|
1858 participants
n=5 Participants
|
|
Gender
Male
|
5862 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: stent implantation until hospital discharge (average 1-3 days)The primary endpoint for this study is delivery success defined as complete passage of the Resolute Integrity stent across the target lesion with full expansion of the stent to the desired diameter at the desired location.
Outcome measures
| Measure |
Group 1 Resolute Integrity™ Stent Primary Stent
n=10733 Stents
A total of 7,740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 10,733 Resolute Integrity™ Stents
|
|---|---|
|
Delivery Success
|
10617 stents
|
SECONDARY outcome
Timeframe: stent implantation until hospital discharge (average 1-3 days)Outcome measures
| Measure |
Group 1 Resolute Integrity™ Stent Primary Stent
n=7740 Participants
A total of 7,740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 10,733 Resolute Integrity™ Stents
|
|---|---|
|
In-hospital MACE (Major Adverse Cardiac Event)
|
126 Participants
|
Adverse Events
Group 1 Resolute Integrity™ Stent Primary Stent
Serious adverse events
| Measure |
Group 1 Resolute Integrity™ Stent Primary Stent
n=7740 participants at risk
A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.
|
|---|---|
|
General disorders
Death
|
0.25%
19/7740 • Number of events 19 • stent implantation until hospital discharge (average 1-3 days)
|
|
Cardiac disorders
Major Adverse Cardiac Event
|
1.6%
126/7740 • Number of events 126 • stent implantation until hospital discharge (average 1-3 days)
|
|
Cardiac disorders
Myocardial Infarction
|
1.3%
103/7740 • Number of events 103 • stent implantation until hospital discharge (average 1-3 days)
|
|
Injury, poisoning and procedural complications
Definite/Probable Stent Thrombosis
|
0.18%
14/7740 • Number of events 14 • stent implantation until hospital discharge (average 1-3 days)
|
|
Surgical and medical procedures
Clinically-driven Target Lesion Revascularization
|
0.13%
10/7740 • Number of events 10 • stent implantation until hospital discharge (average 1-3 days)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee For any publication or presentation of the Protected Materials or any portion thereof, a manuscript of the paper, abstract or other materials will be provided by Consultant to Sponsor for its approval at least sixty (60) days for manuscripts and thirty (30) days for presentations prior to outside submission. Medtronic shall have the right to request reasonable modifications of any manuscript or other materials to be published or presented.
- Publication restrictions are in place
Restriction type: OTHER