Coronary Artery Disease
Conditions
Keywords
CAD, Severely calcified lesion
Brief summary
This is a prospective, single-arm, multi-center study to evaluate the safety and performance of the OAS in treating de novo, severely calcified coronary lesions in adult subjects. Study is going to enroll up to 429 subjects in up to 50 U.S. study sites. The primary safety endpoint is 30-day MACE and primary efficacy endpoint is procedural success. All subjects will be treated with the orbital atherectomy system and adjunctive stent. All subjects will be followed in clinic at 30 days. Additionally, all subjects will have an annual phone call or clinical follow up at each anniversary until study is closed.
Interventions
DEVICEDiamondback 360 Orbital Atherectomy System
Diamondback 360 Orbital Atherectomy System. The (OAS) utilizes a diamond-coated eccentric crown that, while rotating over an atherectomy guide wire, expands the lumen diameter laterally via centrifugal forces (up to a maximum orbit diameter for a given rotational speed and crown diameter). It is a minimally invasive PCI procedure.
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must be 18 or older. * Subjects must have a clinical indication for coronary intervention. * CK and CK-MB must be less than or equal to the upper limit of lab normal value within 8 hours prior to the procedure. * The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure. * The target vessel must be a native coronary artery with a stenosis of \>= 70% and \< 100%. * The target vessel reference diameter must be \>= 2.5mm and \<= 4.0 mm. * The lesion length must not exceed 40 mm. * The target vessel must have a TIMI flow 3 at baseline. * The target lesion must have evidence of severe calcium deposit at the lesion site based on the protocol criterion. * The lesion must be crossable with the study guide wire.
Exclusion criteria
* Inability to understand the study or a history of non-compliance with medical advice. * Unwilling or unable to sign the ORBIT II Informed Consent Form (ICF). * History of any cognitive or mental health status that would interfere with study participation. * Currently enrolled in any other pre-approval investigational study (does not apply to long-term post-market studies unless these studies might clinically interfere with the current study endpoints (e.g., limit use of study-required medication, etc.). * Female subjects who are pregnant or planning to become pregnant within the study period. * Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel without adequate alternative medications. * Known sensitivity to contrast media, which cannot be adequately pre-medicated. * Diagnosed with chronic renal failure or has a serum creatinine level \>2.5 mg/dl. * Experienced acute MI (STEMI or non-STEMI: CK and CK-MB greater than 1 times the upper limit of lab normal) within 30 days prior to index procedure. * History of major cardiovascular intervention within 30 days. * Evidence of current (within 6 months) left ventricular ejection fraction ≤ 25%. * NYHA class III or IV heart failure. * History of a stroke or transient ischemic attack (TIA) within 6 months. * Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months. * History of bleeding diathesis or coagulopathy or intention to refuse blood transfusion if one should become necessary. * Concurrent medical condition with a life expectancy of less than 12 months. * History of immune deficiency. * Uncontrolled insulin dependent diabetes. * Evidence of active infections on the day of the index procedure. * Subject has planned cardiovascular intervention within 60-days post index procedure. * Subject is not an acceptable candidate for emergent coronary artery bypass surgery. * Subject with known allergy to atherectomy lubricant components such as soybean oil, egg yolk phospholipids, glycerin and sodium hydroxide. * Subject with 3 lesions requiring intervention. * Subject with 2 lesions unless the treatment of the lesions is staged. The non target lesion must first be treated at least 12 hours prior to the index procedure. The subject's CK and CK-MB must be less than or equal to one times the upper limit of the lab normal value 12 ± 2 hours post procedure and there were no procedural complications during the first lesion intervention. * Target lesion is located in a native vessel distal to anastomosis with a saphenous vein graft or LIMA/RIMA bypass. * Target vessel has other lesions with greater than 50% diameter stenosis based on visual estimate or on-line QCA. * Target vessel has angiographically visible or suspected thrombus. * Target vessel has a stent from previous PCI. * Target vessel is excessively tortuous. * Target lesion is an ostial location (within 5 mm of ostium) or an unprotected left main lesion. * Target lesion is a bifurcation. * Target lesion has a ≥ 1.5 mm side branch. * Angiographic evidence of a dissection prior to OAS treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint: 30-Day Freedom From Major Adverse Cardiac Events (MACE) | 30 days | OAS safety was measured by a composite of MACE at 30-days post procedure. MACE is composed of: * Cardiac death. * MI - defined as a CK-MB level \> 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave. * TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure. |
| Primary Efficacy Endpoint: Procedural Success | Participants were followed from baseline procedure through the duration of hospital stay, an average of 33.6 hours. | Procedural success was defined as success in facilitating stent delivery with a residual stenosis of \<50% and without the occurrence of an in-hospital MACE in de novo, severely calcified coronary lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Angiographic Success | Baseline procedure, with a mean total procedure time of 52.5 minutes. | Angiographic success was defined as success in facilitating stent delivery with \<50% residual stenosis and without severe angiographic complications. |
| Severe Angiographic Complications | Baseline procedure, with a mean total procedure time of 52.5 minutes. | Severe angiographic complications were defined as severe dissection (Type C to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow. |
| 12-Month Freedom From Major Adverse Cardiac Events (MACE) | 12 months | The safety of the OAS was measured for the secondary safety endpoint consisting of a composite of freedom from MACE through 12 months of follow-up. |
Countries
United States
Participant flow
Recruitment details
The study received approval to enroll up to 429 subjects. Following the introduction of the Electric OAS, the enrollment was expanded to a maximum of 479 subjects, to enroll 100 subjects with the Electric OAS. A total of 443 subjects were enrolled in the study between May 25, 2010 and November 26, 2012 at 49 U.S. study sites.
Pre-assignment details
A subject was considered enrolled when a signed informed consent was in place, all inclusion/no exclusion criteria were met, and the study guidewire had crossed the target lesion.
Participants by arm
| Arm | Count |
|---|---|
| ORBIT II Subjects Subjects enrolled in ORBIT II study. | 443 |
| Total | 443 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 12-Month Follow-up | Data collected after close of 1Y window | 2 |
| 12-Month Follow-up | Death | 16 |
| 12-Month Follow-up | Lost to Follow-up | 4 |
| 12-Month Follow-up | Missed 1-year follow-up | 1 |
| 12-Month Follow-up | Withdrawal by Subject | 2 |
| 30-Day Follow-up | Data collected after close of 30D window | 5 |
| 30-Day Follow-up | Death | 2 |
| 30-Day Follow-up | Missed 30-day follow-up | 3 |
| Enrollment | Atherectomy device not inserted | 3 |
Baseline characteristics
| Characteristic | ORBIT II Subjects |
|---|---|
| Age, Continuous | 71.4 years |
| Race/Ethnicity, Customized Asian | 9 participants |
| Race/Ethnicity, Customized Black or African American | 25 participants |
| Race/Ethnicity, Customized Caucasian | 390 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 15 participants |
| Race/Ethnicity, Customized Native American | 1 participants |
| Race/Ethnicity, Customized Other | 3 participants |
| Sex: Female, Male Female | 157 Participants |
| Sex: Female, Male Male | 286 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 34 / 443 | 0 / 438 |
| serious Total, serious adverse events | 109 / 443 | 70 / 438 |
Outcome results
Primary
Primary Efficacy Endpoint: Procedural Success
Procedural success was defined as success in facilitating stent delivery with a residual stenosis of \<50% and without the occurrence of an in-hospital MACE in de novo, severely calcified coronary lesions.
Time frame: Participants were followed from baseline procedure through the duration of hospital stay, an average of 33.6 hours.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ORBIT II Subjects | Primary Efficacy Endpoint: Procedural Success | 88.9 Percentage of procedures |
Primary
Primary Safety Endpoint: 30-Day Freedom From Major Adverse Cardiac Events (MACE)
OAS safety was measured by a composite of MACE at 30-days post procedure. MACE is composed of: * Cardiac death. * MI - defined as a CK-MB level \> 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave. * TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure.
Time frame: 30 days
Population: A Kaplan-Meier analysis was performed to determine the percent probability that a study participant is free from major adverse cardiac events at 30 days.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ORBIT II Subjects | Primary Safety Endpoint: 30-Day Freedom From Major Adverse Cardiac Events (MACE) | 89.6 Percent probability of Freedom from MACE |
Secondary
12-Month Freedom From Major Adverse Cardiac Events (MACE)
The safety of the OAS was measured for the secondary safety endpoint consisting of a composite of freedom from MACE through 12 months of follow-up.
Time frame: 12 months
Population: A Kaplan-Meier analysis was performed to determine the percent probability that a study participant is free from major adverse cardiac events at 12 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ORBIT II Subjects | 12-Month Freedom From Major Adverse Cardiac Events (MACE) | 83.1 Percent probability of Freedom from MACE |
Secondary
Angiographic Success
Angiographic success was defined as success in facilitating stent delivery with \<50% residual stenosis and without severe angiographic complications.
Time frame: Baseline procedure, with a mean total procedure time of 52.5 minutes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ORBIT II Subjects | Angiographic Success | 91.4 Percentage of procedures |
Secondary
Severe Angiographic Complications
Severe angiographic complications were defined as severe dissection (Type C to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.
Time frame: Baseline procedure, with a mean total procedure time of 52.5 minutes.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ORBIT II Subjects | Severe Angiographic Complications | Type C, D, E, or F Dissection | 15 Participants |
| ORBIT II Subjects | Severe Angiographic Complications | Perforation | 8 Participants |
| ORBIT II Subjects | Severe Angiographic Complications | Persistent Slow Flow | 4 Participants |
| ORBIT II Subjects | Severe Angiographic Complications | Persistent No Reflow | 0 Participants |
| ORBIT II Subjects | Severe Angiographic Complications | Abrupt Closure | 8 Participants |