Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medtronic Cardiac Rhythm and Heart Failure | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stent implantation | Device | Single arm, open label stent implantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | stent implantation until hospital discharge (average 1-3 days) |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital MACE (Major Adverse Cardiac Event) | stent implantation until hospital discharge (average 1-3 days) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The study population will consist of patients with symptomatic ischemic heart disease due to stenotic lesions in coronary arteries or bypass graft that are amenable to percutaneous treatment.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onze Lieve Vrouwe Gasthuis Ziekenhuis | Amsterdam | Netherlands |
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.
Patients were enrolled at 163 centres in Europe, Asia, the Middle East, and Latin America from January 2011 to May 2012.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age of 20 (0.26%) patients not reported by investigators. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | stents | stent implantation until hospital discharge (average 1-3 days) | Stents | Participants |
|
|
stent implantation until hospital discharge (average 1-3 days)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | All Death 0.2% (19/7740) Cardiac Death 0.2% (15/7740) |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frank van Leeuwen, M.D. | Clinical Research Director | +31433566622 | frank.van.leeuwen@medtronic.com |
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Number |
| participants |
|
| Age, Continuous | Age of 20 (0.26%) patients not reported by investigators | Mean | Standard Deviation | years |
|
| Gender | Gender of 20 (0.26%) patients not reported by investigators | Number | participants |
|
|
| Stents |
|
|
| Secondary | In-hospital MACE (Major Adverse Cardiac Event) | Posted | Number | Participants | stent implantation until hospital discharge (average 1-3 days) |
|
|
|
| 126 |
| 7,740 |
| 0 |
| 7,740 |
| Major Adverse Cardiac Event | Cardiac disorders | Defined as in-hospital death, myocardial infarction (Q-wave and non Q-wave), emergent coronary bypass surgery, or repeat target lesion revascularization (clinically driven/clinically indicated) by percutaneous or surgical method |
|
| Myocardial Infarction | Cardiac disorders |
|
| Definite/Probable Stent Thrombosis | Injury, poisoning and procedural complications | According to Academic Research Consortium (ARC) Definition for Stent Thrombosis |
|
| Clinically-driven Target Lesion Revascularization | Surgical and medical procedures | Revascularization at target lesion (TL) with positive functional ischemia study/ischemic symptoms AND angiographic minimal lumen diameter stenosis >=50%, or revascularization of TL with diameter stenosis >=70% without angina/positive functional study |
|
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.
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |