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The purpose of this study is to collect data from real-world use with the Glider Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to support the effectiveness of the Glider PTCA Balloon for crossing into complex coronary lesions.
Observational Study collecting data on commercial cases in which the Glider PTCA Balloon Catheter is used in accordance with the instructions for use. This study includes up 500 patients at up to 50 study sites.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTCA Balloon Angioplasty | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success Rate | Percentage of lesions successfully crossed among those attempted with the Glider PTCA catheter. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from Balloon Slippage | Percentage of inflations with the Glider balloon in which the physician user reports no slippage. | 1 hour |
| Lesion Success Rate | Percentage of lesions with <50% diameter stenosis, or Thrombolysis In Myocardial Infarction (TIMI) 3 flow if side branch is present, without development of MACE during hospital stay. |
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Inclusion Criteria:
Lesion must be successfully crossed with a guidewire without complication (including Chronic Total Occlusions (CTOs))
The Glider balloon may only be used at one lesion during the procedure
The lesion in which the Glider balloon is used must be completed first
The primary lesion treated during the procedure must be treated with the Glider balloon
Intended treatment of a protocol-defined complex lesion that has at least one of the following factors:
Exclusion Criteria:
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All cases of coronary interventions involving the Gliderâ„¢ PTCA Balloon Catheter at participating centers will be reviewed for patient eligibility. Patients from all eligible cases should be invited to sign an IRB-approved Informed Consent.
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| Name | Affiliation | Role |
|---|---|---|
| David Rizik, MD | Scottsdale Healthcare | Principal Investigator |
| William Lombardi, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexian Brothers Heart and Vascualr Institute | Elk Grove Village | Illinois | 60007 | United States | ||
| Washington University in St. Louis |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 48 hours |
| St Louis |
| Missouri |
| 63110 |
| United States |
| York Hospital | York | Pennsylvania | 17403 | United States |
| Cardiovascular Specialists of Texas | Austin | Texas | 78758 | United States |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |