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The aim of this study was to assess effectiveness and safety of Tiger (5Fr) vs Judkins (5Fr) catheters, in coronariography via the right transradial approach.
This was a prospective, randomized, study of paralled design. Consecutive patients with acute coronary syndrome (ACS), eligible for coronary angiography, was randomized after successuful cannulation of right artery and informed consent to either Tiger or Judkins catheters.
analyzed a total of 120 consective diagnostic coronary angioggraphy cases from the right radial approach. Of these 60 cases were performed with single catheter (Tiger) and 60 cases were performed with conventional catheters (Judkins). The patients of both group were overall well balanced for gender, age, risk factors, height, weight and body surface area. Diagnostic angiograms were successfully achieved in all cases via the radial approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiger catheter | Experimental | Tiger simple multipurpose catheter compared to Judkins catheters |
|
| Judkins catheter | Active Comparator | Judkins right and judkins left catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiger catheter | Device |
|
| |
| Judkins catheter |
| Measure | Description | Time Frame |
|---|---|---|
| Produce time for the coronary angiography | Produce time (min) was defined as the time from the insertion of the first diagnostic coronary catheter in the sheath to the exist of the las diagnostic catheter the sheath. | Day 0 (corresponding to time point of produce) assessed by intention - to - tresat analysis (IIT) |
| Measure | Description | Time Frame |
|---|---|---|
| Fluoroscopy time | Fluoroscopy time (min)was defined as fluoroscopy time during the procedure (between groups) | Day 0 (corresponding to time point of produce) |
| Contrast Volume used | contrast volume used (ml) was defined as the contrast volume between groups used for completion of coronary angiogram |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcelo OLIVA, MD | Hospital San Roque | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital San Roque | Córdoba | 5000 | Argentina |
The aim of this study was to assess effectiveness and safety of Tiger vs Judkins catheters, in coronary angiography.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 20, 2017 | Sep 5, 2017 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Device |
|
|
| Day 0 (corresponding to time point of produce) |
| Radial artery Spasm | Radial artery Spasm was defined as the discomfort or pain in the arm, between groups | Day 0 (corresponding to time point of produce). The radial artery spasm was recorded like YES or NOT.(registry did by nurse from beginning to end of coronary angiography) |