Coronary Artery Disease
Conditions
Brief summary
The primary objective of the DELIVER Study is to assess the deliverability of the Resolute Integrity Stent as primary stent or as a secondary cross-over stent following delivery failure of another stent type in real world patients.
Interventions
DEVICEStent implantation
Single arm, open label stent implantation
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Medtronic Vascular
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Minimum legal age (18) * Acceptable candidate for treatment with a drug-eluting stent in accordance with applicable guidelines * Patient has consented to participate and authorized in writing the collection and release of medical information
Exclusion criteria
* Pregnancy * Participating in another study that interferes with study endpoints * Untreatable hypersensitivity or allergies to aspirin, heparin, clopidogrel, zotarolimus or similar drugs or contrast media * Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delivery Success | 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. |
Secondary
| Measure | Time frame |
|---|---|
| In-hospital MACE (Major Adverse Cardiac Event) | stent implantation until hospital discharge (average 1-3 days) |
Countries
Netherlands
Participant flow
Recruitment details
Patients were enrolled at 163 centres in Europe, Asia, the Middle East, and Latin America from January 2011 to May 2012.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7,740 |
| Total | 7,740 |
Baseline characteristics
| Characteristic | Group 1 Resolute Integrity™ Stent Primary Stent |
|---|---|
| Age, Categorical <=18 years | 0 participants |
| Age, Categorical >=65 years | 3662 participants |
| Age, Categorical Between 18 and 65 years | 4058 participants |
| Age, Continuous | 63.5 years STANDARD_DEVIATION 11.2 |
| Gender Female | 1858 participants |
| Gender Male | 5862 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 7,740 |
| serious Total, serious adverse events | 126 / 7,740 |
Outcome results
Primary
Delivery Success
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.
Time frame: stent implantation until hospital discharge (average 1-3 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 Resolute Integrity™ Stent Primary Stent | Delivery Success | 10617 stents |
Secondary
In-hospital MACE (Major Adverse Cardiac Event)
Time frame: stent implantation until hospital discharge (average 1-3 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1 Resolute Integrity™ Stent Primary Stent | In-hospital MACE (Major Adverse Cardiac Event) | 126 Participants |