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Prospective, non-randomized, multicenter study in subjects with coronary artery chronic total occlusions (CTOs). Published results of safety and effectiveness of conventional techniques will be used for comparison. Enrollment of up to 149 subjects with a CTO refractory to currently marketed guidewire use and meeting all inclusion/exclusion criteria at up to 15 US clinical sites. Hypothesis is that the BridgePoint Medical System is safe and effective in treating coronary CTOs compared to CTO literature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BridgePoint Medical System | Experimental | Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recanalization of a coronary chronic total occlusion | Device | Crossing a CTO to allow definitive treatment via balloon angioplasty and/or stent placement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success | Defined as the ability of the BridgePoint Medical System to successfully facilitate placement of a guidewire beyond a chronic total occlusion (CTO) in the true vessel lumen in cases that were otherwise refractory to treatment with a currently marketed guidewire | Intraprocedural |
| 30-day Major Adverse Cardiac Event (MACE) Rate | Defined as cardiac death, Q-wave and non-Q-wave [total creatinine kinase (CK) >2x upper limit of normal with a positive myocardial band (MB) fraction] myocardial infarction (MI), target lesion revascularization (TLR), and emergency bypass surgery. | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Total Procedure Time | Minus any time to determine CTO was refractory to standard guidewire | Intraprocedural |
| Total Procedural Fluoroscopy Time | Minus any time to determine CTO was refractory to standard guidewire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Whitlow, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke's Medical Center | Phoenix | Arizona | 85006 | United States | ||
| Scripps Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22516395 | Derived | Whitlow PL, Burke MN, Lombardi WL, Wyman RM, Moses JW, Brilakis ES, Heuser RR, Rihal CS, Lansky AJ, Thompson CA; FAST-CTOs Trial Investigators. Use of a novel crossing and re-entry system in coronary chronic total occlusions that have failed standard crossing techniques: results of the FAST-CTOs (Facilitated Antegrade Steering Technique in Chronic Total Occlusions) trial. JACC Cardiovasc Interv. 2012 Apr;5(4):393-401. doi: 10.1016/j.jcin.2012.01.014. |
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| ID | Title | Description |
|---|---|---|
| FG000 | BridgePoint Medical System | Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Intraprocedural |
| La Jolla |
| California |
| 92037 |
| United States |
| University of California Davis Heart & Vascular Center | Sacramento | California | 95817 | United States |
| Stanford University Hospital | Stanford | California | 94305 | United States |
| Torrance Memorial Medical Center | Torrance | California | 90505 | United States |
| Yale-New Haven Hospital | New Haven | Connecticut | 06520 | United States |
| Prairie Cardiovascular Consultants | Springfield | Illinois | 62701 | United States |
| Minneapolis Heart Institute, Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic - St. Mary's Hospital | Rochester | Minnesota | 55905 | United States |
| Mid America Heart Institute, St. Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Dallas VA Medical Center | Dallas | Texas | 75216 | United States |
| Intermountain Medical Center | Murray | Utah | 84157 | United States |
| St. Joseph Hospital | Bellingham | Washington | 98225 | United States |
| COMPLETED |
|
| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | BridgePoint Medical System | Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Technical Success | Defined as the ability of the BridgePoint Medical System to successfully facilitate placement of a guidewire beyond a chronic total occlusion (CTO) in the true vessel lumen in cases that were otherwise refractory to treatment with a currently marketed guidewire | Three participants had two CTOs, so there were a total of 150 CTOs in 147 participants. | Posted | Number | 90% Confidence Interval | percentage of CTOs | Intraprocedural | CTOs | Participants |
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| |||||||||||||||||||||||||
| Primary | 30-day Major Adverse Cardiac Event (MACE) Rate | Defined as cardiac death, Q-wave and non-Q-wave [total creatinine kinase (CK) >2x upper limit of normal with a positive myocardial band (MB) fraction] myocardial infarction (MI), target lesion revascularization (TLR), and emergency bypass surgery. | Includes 21 patients with "early" (<30 day) follow-up | Posted | Number | 90% Confidence Interval | percentage of participants | 30 Days |
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| ||||||||||||||||||||||||||||
| Secondary | Total Procedure Time | Minus any time to determine CTO was refractory to standard guidewire | Procedure time data for two participants was not available. | Posted | Mean | Standard Deviation | minutes | Intraprocedural |
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| ||||||||||||||||||||||||||||
| Secondary | Total Procedural Fluoroscopy Time | Minus any time to determine CTO was refractory to standard guidewire | Fluoroscopy time was not available for two participants | Posted | Mean | Standard Deviation | minutes | Intraprocedural |
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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 | BridgePoint Medical System | Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire | 25 | 147 | 61 | 147 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders |
| |||
| Non-Q-Wave Myocardial Infarction (NQWMI) | Cardiac disorders | Defined as total serum creatinine kinase (CK) greater than twice the upper limit of normal with greater than the upper limit of normal myocardial band (CK-MB) |
| ||
| Cerebral Vascular Accident/Stroke | Nervous system disorders |
| |||
| Perforation | Vascular disorders |
| |||
| Pericardial Effusion | Cardiac disorders |
| |||
| Arrhythmia Requiring Treatment | Cardiac disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Enzyme Elevation | Cardiac disorders | Enzyme elevation that did not fit the definition of NQWMI |
| ||
| Untreated Dissection | Vascular disorders |
| |||
| Puncture Site Complication | Vascular disorders |
| |||
| Non-Target Vessel Treatment | Vascular disorders |
| |||
| Other | Vascular disorders | Includes but not limited to: chest pain, hypotension, radiation burn, pulmonary embolism, dermatitis, vomiting, vasovagal reaction, and heart murmur. |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Clinical Affairs | BridgePoint Medical | 763-225-8500 | jschultz@bridgepointmedical.com |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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