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Trial record 1 of 13 for:    orbit II
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Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions (ORBIT II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01092416
Recruitment Status : Completed
First Posted : March 25, 2010
Results First Posted : January 6, 2016
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Cardiovascular Systems Inc

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Coronary Artery Disease
Intervention Device: Diamondback 360 Orbital Atherectomy System
Enrollment 443
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.
Arm/Group Title ORBIT II Subjects
Hide Arm/Group Description Subjects enrolled in ORBIT II study.
Period Title: Enrollment
Started 443
Completed 440
Not Completed 3
Reason Not Completed
Atherectomy device not inserted             3
Period Title: 30-Day Follow-up
Started 440
Completed 430
Not Completed 10
Reason Not Completed
Death             2
Missed 30-day follow-up             3
Data collected after close of 30D window             5
Period Title: 12-Month Follow-up
Started 438
Completed 413
Not Completed 25
Reason Not Completed
Death             16
Lost to Follow-up             4
Withdrawal by Subject             2
Missed 1-year follow-up             1
Data collected after close of 1Y window             2
Arm/Group Title ORBIT II Subjects
Hide Arm/Group Description Subjects enrolled in ORBIT II study.
Overall Number of Baseline Participants 443
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 443 participants
71.4
(37.4 to 92.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 443 participants
Female
157
  35.4%
Male
286
  64.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 443 participants
Caucasian 390
Black or African American 25
Asian 9
Hispanic or Latino 15
Native American 1
Other 3
1.Primary Outcome
Title Primary Safety Endpoint: 30-Day Freedom From Major Adverse Cardiac Events (MACE)
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title ORBIT II Subjects
Hide Arm/Group Description:
Subjects enrolled in ORBIT II study.
Overall Number of Participants Analyzed 443
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent probability of Freedom from MACE
89.6
(86.7 to 92.5)
2.Primary Outcome
Title Primary Efficacy Endpoint: Procedural Success
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title OAS Treatment Group
Hide Arm/Group Description:
Subjects enrolled in ORBIT II study and in whom the atherectomy device was inserted.
Overall Number of Participants Analyzed 440
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of procedures
88.9
(85.5 to 91.6)
3.Secondary Outcome
Title Angiographic Success
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ORBIT II Subjects
Hide Arm/Group Description:
Subjects enrolled in ORBIT II study
Overall Number of Participants Analyzed 443
Measure Type: Number
Unit of Measure: Percentage of procedures
91.4
4.Secondary Outcome
Title Severe Angiographic Complications
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ORBIT II Subjects
Hide Arm/Group Description:
Subjects enrolled in ORBIT II study
Overall Number of Participants Analyzed 443
Measure Type: Number
Unit of Measure: Participants
Type C, D, E, or F Dissection 15
Perforation 8
Persistent Slow Flow 4
Persistent No Reflow 0
Abrupt Closure 8
5.Secondary Outcome
Title 12-Month Freedom From Major Adverse Cardiac Events (MACE)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title ORBIT II Subjects
Hide Arm/Group Description:
Subjects enrolled in ORBIT II study.
Overall Number of Participants Analyzed 443
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent probability of Freedom from MACE
83.1
(79.6 to 86.7)
Time Frame [Not Specified]
Adverse Event Reporting Description Serious Adverse Events reported by sites and adjudicated by the Clinical Events Committee.
 
Arm/Group Title ORBIT II Subjects - 30 Day Results ORBIT II Subjects - 1 Year Results
Hide Arm/Group Description Serious Adverse Events reported out to 30 Days Post-Procedure for Subjects enrolled in ORBIT II study. Serious Adverse Events reported from 31 Days to 1 Year Post-Procedure for Subjects enrolled in ORBIT II study.
All-Cause Mortality
ORBIT II Subjects - 30 Day Results ORBIT II Subjects - 1 Year Results
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
ORBIT II Subjects - 30 Day Results ORBIT II Subjects - 1 Year Results
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   109/443 (24.60%)      70/438 (15.98%)    
Blood and lymphatic system disorders     
Anemia   0/443 (0.00%)  0 9/438 (2.05%)  9
Pancytopenia   0/443 (0.00%)  0 1/438 (0.23%)  1
Cardiac disorders     
Acute MI, Q-wave   4/443 (0.90%)  4 0/438 (0.00%)  0
Acute MI, non Q-wave   39/443 (8.80%)  39 5/438 (1.14%)  5
Angina Pectoris   4/443 (0.90%)  4 23/438 (5.25%)  25
Atrial fibrillation   2/443 (0.45%)  2 9/438 (2.05%)  9
Atrioventricular block, II degree   1/443 (0.23%)  1 1/438 (0.23%)  1
Cardiac/pericardial tamponade   4/443 (0.90%)  4 0/438 (0.00%)  0
Cardiogenic shock   2/443 (0.45%)  2 0/438 (0.00%)  0
Chest pain   2/443 (0.45%)  2 3/438 (0.68%)  3
Endocarditis   1/443 (0.23%)  1 0/438 (0.00%)  0
Non-target vessel revascularization   1/443 (0.23%)  1 3/438 (0.68%)  4
PEA arrest   1/443 (0.23%)  1 0/438 (0.00%)  0
Pericarditis   1/443 (0.23%)  1 0/438 (0.00%)  0
Shock (Acute RV dysfunction and acute blood loss hypovolemic)   1/443 (0.23%)  1 0/438 (0.00%)  0
Sick sinus syndrome   1/443 (0.23%)  1 2/438 (0.46%)  2
Ventricular fibrillation   2/443 (0.45%)  2 0/438 (0.00%)  0
Ventricular tachycardia   1/443 (0.23%)  1 0/438 (0.00%)  0
Ventricular tachycardia/ventricular fibrillation   1/443 (0.23%)  1 0/438 (0.00%)  0
Cardiac death   1/443 (0.23%)  1 12/438 (2.74%)  12
Acute congestive heart failure   0/443 (0.00%)  0 1/438 (0.23%)  1
Aortic valve stenosis   0/443 (0.00%)  0 2/438 (0.46%)  2
Arrhythmia, unspecified   0/443 (0.00%)  0 1/438 (0.23%)  1
Atrial flutter   0/443 (0.00%)  0 1/438 (0.23%)  1
Cardiomyopathy   0/443 (0.00%)  0 1/438 (0.23%)  1
Chronic congestive heart failure, or exacerbation   0/443 (0.00%)  0 8/438 (1.83%)  12
Coronary artery restenosis   0/443 (0.00%)  0 20/438 (4.57%)  22
Heart flutter/nervous feeling in chest   0/443 (0.00%)  0 1/438 (0.23%)  1
Myocarditis   0/443 (0.00%)  0 1/438 (0.23%)  1
Pacemaker end of life   0/443 (0.00%)  0 1/438 (0.23%)  1
Palpitation   0/443 (0.00%)  0 1/438 (0.23%)  1
Sinus bradycardia   0/443 (0.00%)  0 1/438 (0.23%)  1
Eye disorders     
Bilateral cataracts   0/443 (0.00%)  0 1/438 (0.23%)  1
Gastrointestinal disorders     
Colitis   1/443 (0.23%)  1 4/438 (0.91%)  4
Esophageal spasm   1/443 (0.23%)  1 0/438 (0.00%)  0
Gastrointestinal bleeding   3/443 (0.68%)  3 5/438 (1.14%)  5
Nausea and/or vomiting   1/443 (0.23%)  1 0/438 (0.00%)  0
Complicated appendicitis (rupture)   0/443 (0.00%)  0 1/438 (0.23%)  1
Diverticulitis   0/443 (0.00%)  0 1/438 (0.23%)  1
Duodenal ulcer   0/443 (0.00%)  0 1/438 (0.23%)  1
Gastritis   0/443 (0.00%)  0 1/438 (0.23%)  1
Gastroenteritis   0/443 (0.00%)  0 4/438 (0.91%)  4
Gastroparesis   0/443 (0.00%)  0 1/438 (0.23%)  1
Rectocoele repair   0/443 (0.00%)  0 1/438 (0.23%)  1
General disorders     
Non-cardiac death   1/443 (0.23%)  1 4/438 (0.91%)  4
Fever   1/443 (0.23%)  1 0/438 (0.00%)  0
Lower extremity pain   1/443 (0.23%)  1 0/438 (0.00%)  0
Hyponatremia   0/443 (0.00%)  0 1/438 (0.23%)  1
Supratherapeutic INR  [1]  0/443 (0.00%)  0 1/438 (0.23%)  1
Death, unknown cause   0/443 (0.00%)  0 1/438 (0.23%)  1
Back pain   0/443 (0.00%)  0 1/438 (0.23%)  1
Chest pain, non-cardiac   0/443 (0.00%)  0 1/438 (0.23%)  1
Epistaxis   0/443 (0.00%)  0 1/438 (0.23%)  1
Fall/Loss of balance   0/443 (0.00%)  0 2/438 (0.46%)  2
Metabolic acidosis   0/443 (0.00%)  0 2/438 (0.46%)  2
Peripheral edema   0/443 (0.00%)  0 1/438 (0.23%)  1
Trauma   0/443 (0.00%)  0 3/438 (0.68%)  3
Gangrene   0/443 (0.00%)  0 1/438 (0.23%)  1
Hepatobiliary disorders     
Bile duct leak   0/443 (0.00%)  0 1/438 (0.23%)  1
Biloma   0/443 (0.00%)  0 1/438 (0.23%)  1
Cirrhosis   0/443 (0.00%)  0 1/438 (0.23%)  1
Complications post cholecystectomy   0/443 (0.00%)  0 1/438 (0.23%)  1
Elevated liver function tests   0/443 (0.00%)  0 1/438 (0.23%)  1
Gallstone   0/443 (0.00%)  0 2/438 (0.46%)  2
Gangrenous gallbladder   0/443 (0.00%)  0 1/438 (0.23%)  1
Infections and infestations     
Infection at access site   1/443 (0.23%)  1 0/438 (0.00%)  0
Left arm AV graft infection   1/443 (0.23%)  1 0/438 (0.00%)  0
Flu   0/443 (0.00%)  0 1/438 (0.23%)  1
Respiratory infection   0/443 (0.00%)  0 2/438 (0.46%)  2
Bacteremia   0/443 (0.00%)  0 1/438 (0.23%)  1
Infection at pacemaker site   0/443 (0.00%)  0 1/438 (0.23%)  1
Sepsis   0/443 (0.00%)  0 2/438 (0.46%)  2
Skin infection   0/443 (0.00%)  0 1/438 (0.23%)  1
Musculoskeletal and connective tissue disorders     
Bone fracture   1/443 (0.23%)  1 6/438 (1.37%)  6
Arthroplasty revision   0/443 (0.00%)  0 1/438 (0.23%)  1
Carpal tunnel syndrome   0/443 (0.00%)  0 1/438 (0.23%)  1
Cellulitis   0/443 (0.00%)  0 3/438 (0.68%)  3
Gout   0/443 (0.00%)  0 2/438 (0.46%)  2
Hernia   0/443 (0.00%)  0 1/438 (0.23%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer   0/443 (0.00%)  0 3/438 (0.68%)  3
Breast cancer   0/443 (0.00%)  0 2/438 (0.46%)  2
Thyroid neoplasm   0/443 (0.00%)  0 1/438 (0.23%)  1
Lung cancer   0/443 (0.00%)  0 2/438 (0.46%)  2
Myelodysplastic syndrome   0/443 (0.00%)  0 1/438 (0.23%)  1
Myeloma   0/443 (0.00%)  0 1/438 (0.23%)  1
Rectal cancer   0/443 (0.00%)  0 1/438 (0.23%)  1
Nervous system disorders     
Cerebrovascular accident (CVA)   3/443 (0.68%)  3 2/438 (0.46%)  2
Sundowning/ICU "psychosis"   1/443 (0.23%)  1 0/438 (0.00%)  0
Anxiety   0/443 (0.00%)  0 1/438 (0.23%)  1
Encephalopathy   0/443 (0.00%)  0 1/438 (0.23%)  1
Mental status changes   0/443 (0.00%)  0 2/438 (0.46%)  2
Panic attack   0/443 (0.00%)  0 1/438 (0.23%)  1
Stroke   0/443 (0.00%)  0 1/438 (0.23%)  1
Syncope   0/443 (0.00%)  0 8/438 (1.83%)  9
Tinnitus   0/443 (0.00%)  0 1/438 (0.23%)  1
Transient ischemic attack (TIA)   0/443 (0.00%)  0 2/438 (0.46%)  2
Vasovagal reaction   0/443 (0.00%)  0 1/438 (0.23%)  1
Spinal stenosis   0/443 (0.00%)  0 1/438 (0.23%)  1
Renal and urinary disorders     
Renal insufficiency   1/443 (0.23%)  1 1/438 (0.23%)  1
Urinary tract infection (UTI)   1/443 (0.23%)  1 5/438 (1.14%)  5
Acute renal failure   0/443 (0.00%)  0 6/438 (1.37%)  6
Chronic renal failure, or exacerbation   0/443 (0.00%)  0 2/438 (0.46%)  2
Hematuria   0/443 (0.00%)  0 1/438 (0.23%)  1
Obstructive uropathy   0/443 (0.00%)  0 1/438 (0.23%)  1
Renal calculi   0/443 (0.00%)  0 1/438 (0.23%)  1
Urinary frequency   0/443 (0.00%)  0 5/438 (1.14%)  5
Reproductive system and breast disorders     
Gynecomastia   0/443 (0.00%)  0 1/438 (0.23%)  1
Respiratory, thoracic and mediastinal disorders     
Anoxia due to aspiration   1/443 (0.23%)  1 0/438 (0.00%)  0
Aspiration   1/443 (0.23%)  1 0/438 (0.00%)  0
Bronchitis   1/443 (0.23%)  1 1/438 (0.23%)  1
COPD   1/443 (0.23%)  1 7/438 (1.60%)  14
Dyspnea/Shortness of breath   1/443 (0.23%)  1 2/438 (0.46%)  3
Pneumonia   2/443 (0.45%)  2 6/438 (1.37%)  7
Respiratory failure   1/443 (0.23%)  1 6/438 (1.37%)  6
Respiratory failure, requiring intubation   1/443 (0.23%)  1 0/438 (0.00%)  0
Hypoxia   0/443 (0.00%)  0 2/438 (0.46%)  2
Multiple lymphadenopathy (on chest CT)   0/443 (0.00%)  0 1/438 (0.23%)  1
Surgical and medical procedures     
Coronary artery embolism of air, plaque, thrombosis, or debris   3/443 (0.68%)  3 0/438 (0.00%)  0
Slow flow or no reflow phenomena   3/443 (0.68%)  3 0/438 (0.00%)  0
Thrombosis formation at site of treated lesion   1/443 (0.23%)  1 0/438 (0.00%)  0
Coronary vessel dissection present   23/443 (5.19%)  23 0/438 (0.00%)  0
Coronary vessel perforation present   8/443 (1.81%)  8 0/438 (0.00%)  0
Non-coronary right ventricle vessel perforation present   1/443 (0.23%)  1 0/438 (0.00%)  0
Knee replacement   0/443 (0.00%)  0 2/438 (0.46%)  2
Vascular disorders     
Hematoma at access site, requiring intervention   1/443 (0.23%)  1 0/438 (0.00%)  0
Hemorrhage, major, requiring transfusion   3/443 (0.68%)  3 0/438 (0.00%)  0
Hypotension   2/443 (0.45%)  2 2/438 (0.46%)  2
Peripheral artery pseudoaneurysm   3/443 (0.68%)  3 0/438 (0.00%)  0
Peripheral artery/vascular disease   2/443 (0.45%)  2 9/438 (2.05%)  10
Pulmonary embolism   1/443 (0.23%)  1 0/438 (0.00%)  0
Carotid artery disease   0/443 (0.00%)  0 2/438 (0.46%)  2
Deep vein thrombosis   0/443 (0.00%)  0 2/438 (0.46%)  2
Hypertension   0/443 (0.00%)  0 1/438 (0.23%)  1
Hematoma   0/443 (0.00%)  0 1/438 (0.23%)  1
Cerebral artery aneurysm   0/443 (0.00%)  0 2/438 (0.46%)  2
Indicates events were collected by systematic assessment
[1]
International Normalized Ratio/Prothrombin time
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ORBIT II Subjects - 30 Day Results ORBIT II Subjects - 1 Year Results
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/443 (7.67%)      0/438 (0.00%)    
Surgical and medical procedures     
Angiographic Complications   34/443 (7.67%)  34 0/438 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Any previously unpublished information provided to the Investigators by the Sponsor is confidential and will remain the sole property of the Sponsor. The Investigator agrees to use this information only in accomplishing this study not use it for other purposes without the Sponsor’s written consent. An Investigator can generate additional publication ideas based on the trial data. The Sponsor reserves the right to review the manuscript prior to submission in order to verify accuracy of the data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Project Manager
Organization: Cardiovascular Systems, Inc.
Phone: 6512591600
EMail: clinicaltrials_csi@csi360.com
Publications of Results:
Layout table for additonal information
Responsible Party: Cardiovascular Systems Inc
ClinicalTrials.gov Identifier: NCT01092416    
Other Study ID Numbers: ORBIT II
First Submitted: March 23, 2010
First Posted: March 25, 2010
Results First Submitted: September 1, 2015
Results First Posted: January 6, 2016
Last Update Posted: February 12, 2020