Coronary Artery Chronic Total Occlusion
Conditions
Keywords
CTO, chronic total occlusion, CAD, coronary artery disease, interventional cardiology, revascularization, recanalization
Brief summary
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.
Interventions
DEVICERecanalization of a coronary chronic total occlusion
Crossing a CTO to allow definitive treatment via balloon angioplasty and/or stent placement
Sponsors
BridgePoint Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* suitable candidate for non-emergent, coronary angioplasty * documented coronary CTO lesion with the following characteristics: a) Thrombolysis in Myocardial Infarction (TIMI) 0 flow for at least 90 days; b) satisfactory distal vessel visualization; and c) refractory to currently marketed guidewire crossing via 1 of the following: 1. previous failed attempt to cross CTO within the past 12 months; or 2. unsuccessful CTO crossing w/ guidewire (10-15 min fluoro time); or 3. attempt to cross CTO w/ guidewire results in subintimal guidewire * angina or ischemia caused by the occluded artery * at least 18 years of age * Body Mass Index (BMI) \< 40 * left ventricle ejection fraction \> 20% * sign the Informed Consent Form
Exclusion criteria
* saphenous vein graft (SVG) CTO or an in-stent CTO * aorto-ostial CTO location. (Ostial bifurcation origins may be considered) * intolerance to aspirin or a neutropenic response to Ticlopidine/Clopidogrel * appearance of thrombus or intraluminal filling defects * severe cerebrovascular disease (history of stroke or TIA within 1 month) * cardiac intervention within two weeks of the procedure * renal insufficiency (serum creatinine of \> 2.3 mg/dl) * active gastrointestinal bleeding * active infection or fever that may be due to infection * life expectancy \< 2 years due to other illnesses * significant anemia (hemoglobin \< 8.0 mg / dl) * severe uncontrolled systemic hypertension * severe electrolyte imbalance * anaphylaxis to angiographic contrast media unless appropriately medicated * congestive heart failure \[New York Heart Association (NYHA) Class IV\] * unstable angina requiring emergent percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) * recent myocardial infarction (MI)(within the past two weeks) * uncontrolled diabetes * participation in another investigational protocol * unwillingness or inability to comply with any protocol requirements * pregnant or nursing * extensive dissection from refractory guidewire use * crossing CTO (true lumen) w/ guidewire within 10-15 min of fluoro time
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | Intraprocedural | 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 |
| 30-day Major Adverse Cardiac Event (MACE) Rate | 30 Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Procedure Time | Intraprocedural | Minus any time to determine CTO was refractory to standard guidewire |
| Total Procedural Fluoroscopy Time | Intraprocedural | Minus any time to determine CTO was refractory to standard guidewire |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BridgePoint Medical System Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire | 147 |
| Total | 147 |
Baseline characteristics
| Characteristic | BridgePoint Medical System |
|---|---|
| Age Continuous | 63.3 years STANDARD_DEVIATION 9.1 |
| Region of Enrollment United States | 147 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 127 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 61 / 147 |
| serious Total, serious adverse events | 25 / 147 |
Outcome results
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.
Time frame: 30 Days
Population: Includes 21 patients with early (\<30 day) follow-up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BridgePoint Medical System | 30-day Major Adverse Cardiac Event (MACE) Rate | All participants | 4.8 percentage of participants |
| BridgePoint Medical System | 30-day Major Adverse Cardiac Event (MACE) Rate | Patients with at least 30-days follow-up (n=136) | 5.1 percentage of participants |
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
Time frame: Intraprocedural
Population: Three participants had two CTOs, so there were a total of 150 CTOs in 147 participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BridgePoint Medical System | Technical Success | 77 percentage of CTOs |
Secondary
Total Procedural Fluoroscopy Time
Minus any time to determine CTO was refractory to standard guidewire
Time frame: Intraprocedural
Population: Fluoroscopy time was not available for two participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BridgePoint Medical System | Total Procedural Fluoroscopy Time | 44 minutes | Standard Deviation 25 |
Secondary
Total Procedure Time
Minus any time to determine CTO was refractory to standard guidewire
Time frame: Intraprocedural
Population: Procedure time data for two participants was not available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BridgePoint Medical System | Total Procedure Time | 105 minutes | Standard Deviation 54 |