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Open label, single-arm trial to study the safety and effectiveness of the Sprinter Legend 1.25 mm angioplasty balloon.
The study examines acute outcomes when the Sprinter Legend 1.25mm balloon catheter is used for enlarging coronary luminal diameters during PCI procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trial Arm | Experimental | All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Coronary Intervention | Procedure | Balloon angioplasty of a severely stenotic coronary lesion with the Sprinter Legend 1.25mm Balloon. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Success | Procedural Success defined as delivery of the balloon to the target lesion, no evidence of perforation or dissection and restoration of normal blood flow at the end of the procedure. | 1-3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardic Events (MACE) | Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction, emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods. | 1-3 days |
| Vessel Perforation (Clinical) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Kandzari, MD | Scripps Green Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Green Hospital | La Jolla | California | 92037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21351225 | Result | Kandzari DE, Zankar AA, Teirstein PS, Brilakis ES, Banerjee S, Price MJ, Stinis CT, Hudson PA, Dahle TG, Eng M, Brown R, Ferguson A, Addo TA, Popma JJ. Clinical outcomes following predilation with a novel 1.25-mm diameter angioplasty catheter. Catheter Cardiovasc Interv. 2011 Mar 1;77(4):510-4. doi: 10.1002/ccd.22734. Epub 2010 Nov 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Balloon Angioplasty | All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Balloon Angioplasty | All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Procedural Success | Procedural Success defined as delivery of the balloon to the target lesion, no evidence of perforation or dissection and restoration of normal blood flow at the end of the procedure. | Posted | Number | Percent of Participants | 1-3 days |
|
|
1-3 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Balloon Angioplasty | All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| K. Bogdanovich | Medtronic Cardiovascular | rs.medtroniccardiovascularclinicaltrials@medtronic.com |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006331 | Heart Diseases |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Sprinter Legend 1.25mm Balloon Catheter | Device | Balloon Angioplasty |
|
Clinical vessel perforation is classified as requring additional treatment, or resulting in significant pericardial effusion, acute closure, myocardial infarction, or death. |
| 1-3 days |
| Device Success | Device Success defined as successful delivery of the balloon to the target lesion, dilatation of the lesion using the study device, and no evidence of arterial perforation, dissection, arrhythmias, or reduction in blood flow. | 1-3 days |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Major Adverse Cardic Events (MACE) | Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction, emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods. | Posted | Number | Percent of Participants | 1-3 days |
|
|
|
| Secondary | Vessel Perforation (Clinical) | Clinical vessel perforation is classified as requring additional treatment, or resulting in significant pericardial effusion, acute closure, myocardial infarction, or death. | Posted | Number | Percent of Participants | 1-3 days |
|
|
|
| Secondary | Device Success | Device Success defined as successful delivery of the balloon to the target lesion, dilatation of the lesion using the study device, and no evidence of arterial perforation, dissection, arrhythmias, or reduction in blood flow. | Posted | Number | Percent of Participants | 1-3 days |
|
|
|
| 6 |
| 51 |
| 0 |
| 51 |
| Pericardial Effusion | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vessel Puncture Site Haematoma | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac Enzymes Increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
Investigator and or Participating lnstitution may publish the results of work performed in accordance with the Publication Strategy described in the Clinical Investigational Plan; provided, however, that any such publication or presentation shall be at a time determined by Medtronic and shall be provided to Medtronic for review at least 60 days prior to submission or presentation, for a determination by Medtronic of whether Confidential lnformation is disclosed.
| D014652 |
| Vascular Diseases |
| D019060 | Minimally Invasive Surgical Procedures |