ORBIT II: Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions

• Sponsor: Cardiovascular Systems Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01092416
• Collaborator: (none)
• Enrollment: 443
• Locations: 51
• Duration (Months): 68
• Patients Per Site: 8.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: Diamondback 360 Orbital Atherectomy System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 443 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pivotal Trial to Evaluate the Safety and Efficacy of the Diamondback 360°® Orbital Atherectomy System in Treating De Novo, Severely Calcified Coronary Lesions (ORBIT II)
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2016

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Trinity Hospital	Birmingham	Alabama	United States	35213
2	Baptist Montgomery South	Montgomery	Alabama	United States	36116
3	Mercy Gilbert	Gilbert	Arizona	United States	85297
4	Cedar Sinai Los Angeles	Beverly Hills	California	United States	90210
5	Good Samaritan Hospital	Los Angeles	California	United States	90017
6	Eisenhower Medical Center	Palm Springs	California	United States	92270
7	Desert Cardiology Center	Rancho Mirage	California	United States	92270
8	Sutter Memorial Hospital	Sacramento	California	United States	95825
9	Florida Hospital Memorial	Daytona Beach	Florida	United States	32117
10	North Florida Regional	Gainesville	Florida	United States	32614
11	Munroe Regional Medical Center	Ocala	Florida	United States	34471
12	Florida Hospital	Orlando	Florida	United States	32803
13	Orlando Regional	Orlando	Florida	United States	32806
14	Palm Beach Gardens	Palm Beach Gardens	Florida	United States	33410
15	Winter Haven	Winter Haven	Florida	United States	33881
16	Emory University	Atlanta	Georgia	United States	30322
17	Indiana Heart Hospital	Indianapolis	Indiana	United States	46250
18	Saint Vincents Indianapolis	Indianapolis	Indiana	United States	46290
19	Community Hospital	Munster	Indiana	United States	46321
20	Iowa Heart	Des Moines	Iowa	United States	50314
21	Kansas University Medical Center	Kansas City	Kansas	United States	66160
22	King's Daughters / Kentucky Heart Foundation	Ashland	Kentucky	United States	41101
23	Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
24	Maine Medical Center	Portland	Maine	United States	04102
25	Cape Cod Research Institute	Hyannis	Massachusetts	United States	02601
26	Detroit Medical Center	Detroit	Michigan	United States	48201-2018
27	St. John's Hospital	Detroit	Michigan	United States	48236
28	St. Joseph Mercy	Pontiac	Michigan	United States	48341
29	Lakeland	Saint Joseph	Michigan	United States	49085
30	Mercy Hospital	Coon Rapids	Minnesota	United States	55433
31	Abbott Northwestern	Minneapolis	Minnesota	United States	55407
32	United Heart & Vascular	Saint Paul	Minnesota	United States	55102
33	North Mississippi Medical Center	Tupelo	Mississippi	United States	38801
34	Saint Michaels	Newark	New Jersey	United States	07102
35	Valley Hospital	Ridgewood	New Jersey	United States	07450
36	New York Methodist Hospital	Brooklyn	New York	United States	71878
37	Columbia University Medical Center	New York	New York	United States	10032
38	Lenox Hill	New York	New York	United States	10075
39	St. Francis	Roslyn	New York	United States	11576
40	Good Samaritan Dayton	Dayton	Ohio	United States	45405
41	Oklahoma Heart	Oklahoma City	Oklahoma	United States	73120
42	The Heart and Vascular Center	Beaver	Pennsylvania	United States	15009
43	Bryn Mawr / Lankenau	Bryn Mawr	Pennsylvania	United States	19010
44	St. Mary's	Langhorne	Pennsylvania	United States	19047
45	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania	United States	19104
46	Baptist Memorial Hospital-DeSoto	Memphis	Tennessee	United States	38120
47	Baylor	Dallas	Texas	United States	75226
48	Memorial Hermann	Houston	Texas	United States	77030
49	St. Luke's	Houston	Texas	United States	77030
50	Davis Hospital	Layton	Utah	United States	84041
51	Saint Joe Bellingham / North Cascade Cardiology	Bellingham	Washington	United States	98225

Sponsors and Collaborators

• Cardiovascular Systems Inc

Investigators

• Principal Investigator: Jeffrey Chambers, MD, Metropolitan Cardiology Consutants

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cardiovascular Systems Inc
• ClinicalTrials.gov Identifier: NCT01092416
• Other Study ID Numbers: ORBIT II
• First Posted: Mar 25, 2010
• Last Update Posted: Feb 12, 2020
• Last Verified: Jan 1, 2020

• Keywords provided by Cardiovascular Systems Inc: CAD; Severely calcified lesion
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

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 Detail	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
Arm/Group Description	Subjects enrolled in ORBIT II study.
Period Title: Enrollment
STARTED	443
COMPLETED	440
NOT COMPLETED	3
Period Title: Enrollment
STARTED	440
COMPLETED	430
NOT COMPLETED	10
Period Title: Enrollment
STARTED	438
COMPLETED	413
NOT COMPLETED	25

Baseline Characteristics

Arm/Group Title	ORBIT II Subjects
Arm/Group Description	Subjects enrolled in ORBIT II study.
Overall Participants	443
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	71.4
Sex: Female, Male (Count of Participants)
Female	157 35.4%
Male	286 64.6%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	390 88%
Black or African American	25 5.6%
Asian	9 2%
Hispanic or Latino	15 3.4%
Native American	1 0.2%
Other	3 0.7%

Outcome Measures

1. Primary Outcome

Title	Primary Safety Endpoint: 30-Day Freedom From Major Adverse Cardiac Events (MACE)
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

Outcome Measure Data

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
Arm/Group Description	Subjects enrolled in ORBIT II study.
Measure Participants	443
Number (95% Confidence Interval) [Percent probability of Freedom from MACE]	89.6

2. Secondary Outcome

Title	Angiographic Success
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ORBIT II Subjects
Arm/Group Description	Subjects enrolled in ORBIT II study
Measure Participants	443
Number [Percentage of procedures]	91.4

3. Secondary Outcome

Title	Severe Angiographic Complications
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ORBIT II Subjects
Arm/Group Description	Subjects enrolled in ORBIT II study
Measure Participants	443
Type C, D, E, or F Dissection	15 3.4%
Perforation	8 1.8%
Persistent Slow Flow	4 0.9%
Persistent No Reflow	0 0%
Abrupt Closure	8 1.8%

4. Secondary Outcome

Title	12-Month Freedom From Major Adverse Cardiac Events (MACE)
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

Outcome Measure Data

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
Arm/Group Description	Subjects enrolled in ORBIT II study.
Measure Participants	443
Number (95% Confidence Interval) [Percent probability of Freedom from MACE]	83.1

5. Primary Outcome

Title	Primary Efficacy Endpoint: Procedural Success
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OAS Treatment Group
Arm/Group Description	Subjects enrolled in ORBIT II study and in whom the atherectomy device was inserted.
Measure Participants	440
Number (95% Confidence Interval) [Percentage of procedures]	88.9

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
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 (24.6%)		70/438 (16%)
Blood and lymphatic system disorders
Anemia	0/443 (0%)	0	9/438 (2.1%)	9
Pancytopenia	0/443 (0%)	0	1/438 (0.2%)	1
Cardiac disorders
Acute MI, Q-wave	4/443 (0.9%)	4	0/438 (0%)	0
Acute MI, non Q-wave	39/443 (8.8%)	39	5/438 (1.1%)	5
Angina Pectoris	4/443 (0.9%)	4	23/438 (5.3%)	25
Atrial fibrillation	2/443 (0.5%)	2	9/438 (2.1%)	9
Atrioventricular block, II degree	1/443 (0.2%)	1	1/438 (0.2%)	1
Cardiac/pericardial tamponade	4/443 (0.9%)	4	0/438 (0%)	0
Cardiogenic shock	2/443 (0.5%)	2	0/438 (0%)	0
Chest pain	2/443 (0.5%)	2	3/438 (0.7%)	3
Endocarditis	1/443 (0.2%)	1	0/438 (0%)	0
Non-target vessel revascularization	1/443 (0.2%)	1	3/438 (0.7%)	4
PEA arrest	1/443 (0.2%)	1	0/438 (0%)	0
Pericarditis	1/443 (0.2%)	1	0/438 (0%)	0
Shock (Acute RV dysfunction and acute blood loss hypovolemic)	1/443 (0.2%)	1	0/438 (0%)	0
Sick sinus syndrome	1/443 (0.2%)	1	2/438 (0.5%)	2
Ventricular fibrillation	2/443 (0.5%)	2	0/438 (0%)	0
Ventricular tachycardia	1/443 (0.2%)	1	0/438 (0%)	0
Ventricular tachycardia/ventricular fibrillation	1/443 (0.2%)	1	0/438 (0%)	0
Cardiac death	1/443 (0.2%)	1	12/438 (2.7%)	12
Acute congestive heart failure	0/443 (0%)	0	1/438 (0.2%)	1
Aortic valve stenosis	0/443 (0%)	0	2/438 (0.5%)	2
Arrhythmia, unspecified	0/443 (0%)	0	1/438 (0.2%)	1
Atrial flutter	0/443 (0%)	0	1/438 (0.2%)	1
Cardiomyopathy	0/443 (0%)	0	1/438 (0.2%)	1
Chronic congestive heart failure, or exacerbation	0/443 (0%)	0	8/438 (1.8%)	12
Coronary artery restenosis	0/443 (0%)	0	20/438 (4.6%)	22
Heart flutter/nervous feeling in chest	0/443 (0%)	0	1/438 (0.2%)	1
Myocarditis	0/443 (0%)	0	1/438 (0.2%)	1
Pacemaker end of life	0/443 (0%)	0	1/438 (0.2%)	1
Palpitation	0/443 (0%)	0	1/438 (0.2%)	1
Sinus bradycardia	0/443 (0%)	0	1/438 (0.2%)	1
Eye disorders
Bilateral cataracts	0/443 (0%)	0	1/438 (0.2%)	1
Gastrointestinal disorders
Colitis	1/443 (0.2%)	1	4/438 (0.9%)	4
Esophageal spasm	1/443 (0.2%)	1	0/438 (0%)	0
Gastrointestinal bleeding	3/443 (0.7%)	3	5/438 (1.1%)	5
Nausea and/or vomiting	1/443 (0.2%)	1	0/438 (0%)	0
Complicated appendicitis (rupture)	0/443 (0%)	0	1/438 (0.2%)	1
Diverticulitis	0/443 (0%)	0	1/438 (0.2%)	1
Duodenal ulcer	0/443 (0%)	0	1/438 (0.2%)	1
Gastritis	0/443 (0%)	0	1/438 (0.2%)	1
Gastroenteritis	0/443 (0%)	0	4/438 (0.9%)	4
Gastroparesis	0/443 (0%)	0	1/438 (0.2%)	1
Rectocoele repair	0/443 (0%)	0	1/438 (0.2%)	1
General disorders
Non-cardiac death	1/443 (0.2%)	1	4/438 (0.9%)	4
Fever	1/443 (0.2%)	1	0/438 (0%)	0
Lower extremity pain	1/443 (0.2%)	1	0/438 (0%)	0
Hyponatremia	0/443 (0%)	0	1/438 (0.2%)	1
Supratherapeutic INR	0/443 (0%)	0	1/438 (0.2%)	1
Death, unknown cause	0/443 (0%)	0	1/438 (0.2%)	1
Back pain	0/443 (0%)	0	1/438 (0.2%)	1
Chest pain, non-cardiac	0/443 (0%)	0	1/438 (0.2%)	1
Epistaxis	0/443 (0%)	0	1/438 (0.2%)	1
Fall/Loss of balance	0/443 (0%)	0	2/438 (0.5%)	2
Metabolic acidosis	0/443 (0%)	0	2/438 (0.5%)	2
Peripheral edema	0/443 (0%)	0	1/438 (0.2%)	1
Trauma	0/443 (0%)	0	3/438 (0.7%)	3
Gangrene	0/443 (0%)	0	1/438 (0.2%)	1
Hepatobiliary disorders
Bile duct leak	0/443 (0%)	0	1/438 (0.2%)	1
Biloma	0/443 (0%)	0	1/438 (0.2%)	1
Cirrhosis	0/443 (0%)	0	1/438 (0.2%)	1
Complications post cholecystectomy	0/443 (0%)	0	1/438 (0.2%)	1
Elevated liver function tests	0/443 (0%)	0	1/438 (0.2%)	1
Gallstone	0/443 (0%)	0	2/438 (0.5%)	2
Gangrenous gallbladder	0/443 (0%)	0	1/438 (0.2%)	1
Infections and infestations
Infection at access site	1/443 (0.2%)	1	0/438 (0%)	0
Left arm AV graft infection	1/443 (0.2%)	1	0/438 (0%)	0
Flu	0/443 (0%)	0	1/438 (0.2%)	1
Respiratory infection	0/443 (0%)	0	2/438 (0.5%)	2
Bacteremia	0/443 (0%)	0	1/438 (0.2%)	1
Infection at pacemaker site	0/443 (0%)	0	1/438 (0.2%)	1
Sepsis	0/443 (0%)	0	2/438 (0.5%)	2
Skin infection	0/443 (0%)	0	1/438 (0.2%)	1
Musculoskeletal and connective tissue disorders
Bone fracture	1/443 (0.2%)	1	6/438 (1.4%)	6
Arthroplasty revision	0/443 (0%)	0	1/438 (0.2%)	1
Carpal tunnel syndrome	0/443 (0%)	0	1/438 (0.2%)	1
Cellulitis	0/443 (0%)	0	3/438 (0.7%)	3
Gout	0/443 (0%)	0	2/438 (0.5%)	2
Hernia	0/443 (0%)	0	1/438 (0.2%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer	0/443 (0%)	0	3/438 (0.7%)	3
Breast cancer	0/443 (0%)	0	2/438 (0.5%)	2
Thyroid neoplasm	0/443 (0%)	0	1/438 (0.2%)	1
Lung cancer	0/443 (0%)	0	2/438 (0.5%)	2
Myelodysplastic syndrome	0/443 (0%)	0	1/438 (0.2%)	1
Myeloma	0/443 (0%)	0	1/438 (0.2%)	1
Rectal cancer	0/443 (0%)	0	1/438 (0.2%)	1
Nervous system disorders
Cerebrovascular accident (CVA)	3/443 (0.7%)	3	2/438 (0.5%)	2
Sundowning/ICU "psychosis"	1/443 (0.2%)	1	0/438 (0%)	0
Anxiety	0/443 (0%)	0	1/438 (0.2%)	1
Encephalopathy	0/443 (0%)	0	1/438 (0.2%)	1
Mental status changes	0/443 (0%)	0	2/438 (0.5%)	2
Panic attack	0/443 (0%)	0	1/438 (0.2%)	1
Stroke	0/443 (0%)	0	1/438 (0.2%)	1
Syncope	0/443 (0%)	0	8/438 (1.8%)	9
Tinnitus	0/443 (0%)	0	1/438 (0.2%)	1
Transient ischemic attack (TIA)	0/443 (0%)	0	2/438 (0.5%)	2
Vasovagal reaction	0/443 (0%)	0	1/438 (0.2%)	1
Spinal stenosis	0/443 (0%)	0	1/438 (0.2%)	1
Renal and urinary disorders
Renal insufficiency	1/443 (0.2%)	1	1/438 (0.2%)	1
Urinary tract infection (UTI)	1/443 (0.2%)	1	5/438 (1.1%)	5
Acute renal failure	0/443 (0%)	0	6/438 (1.4%)	6
Chronic renal failure, or exacerbation	0/443 (0%)	0	2/438 (0.5%)	2
Hematuria	0/443 (0%)	0	1/438 (0.2%)	1
Obstructive uropathy	0/443 (0%)	0	1/438 (0.2%)	1
Renal calculi	0/443 (0%)	0	1/438 (0.2%)	1
Urinary frequency	0/443 (0%)	0	5/438 (1.1%)	5
Reproductive system and breast disorders
Gynecomastia	0/443 (0%)	0	1/438 (0.2%)	1
Respiratory, thoracic and mediastinal disorders
Anoxia due to aspiration	1/443 (0.2%)	1	0/438 (0%)	0
Aspiration	1/443 (0.2%)	1	0/438 (0%)	0
Bronchitis	1/443 (0.2%)	1	1/438 (0.2%)	1
COPD	1/443 (0.2%)	1	7/438 (1.6%)	14
Dyspnea/Shortness of breath	1/443 (0.2%)	1	2/438 (0.5%)	3
Pneumonia	2/443 (0.5%)	2	6/438 (1.4%)	7
Respiratory failure	1/443 (0.2%)	1	6/438 (1.4%)	6
Respiratory failure, requiring intubation	1/443 (0.2%)	1	0/438 (0%)	0
Hypoxia	0/443 (0%)	0	2/438 (0.5%)	2
Multiple lymphadenopathy (on chest CT)	0/443 (0%)	0	1/438 (0.2%)	1
Surgical and medical procedures
Coronary artery embolism of air, plaque, thrombosis, or debris	3/443 (0.7%)	3	0/438 (0%)	0
Slow flow or no reflow phenomena	3/443 (0.7%)	3	0/438 (0%)	0
Thrombosis formation at site of treated lesion	1/443 (0.2%)	1	0/438 (0%)	0
Coronary vessel dissection present	23/443 (5.2%)	23	0/438 (0%)	0
Coronary vessel perforation present	8/443 (1.8%)	8	0/438 (0%)	0
Non-coronary right ventricle vessel perforation present	1/443 (0.2%)	1	0/438 (0%)	0
Knee replacement	0/443 (0%)	0	2/438 (0.5%)	2
Vascular disorders
Hematoma at access site, requiring intervention	1/443 (0.2%)	1	0/438 (0%)	0
Hemorrhage, major, requiring transfusion	3/443 (0.7%)	3	0/438 (0%)	0
Hypotension	2/443 (0.5%)	2	2/438 (0.5%)	2
Peripheral artery pseudoaneurysm	3/443 (0.7%)	3	0/438 (0%)	0
Peripheral artery/vascular disease	2/443 (0.5%)	2	9/438 (2.1%)	10
Pulmonary embolism	1/443 (0.2%)	1	0/438 (0%)	0
Carotid artery disease	0/443 (0%)	0	2/438 (0.5%)	2
Deep vein thrombosis	0/443 (0%)	0	2/438 (0.5%)	2
Hypertension	0/443 (0%)	0	1/438 (0.2%)	1
Hematoma	0/443 (0%)	0	1/438 (0.2%)	1
Cerebral artery aneurysm	0/443 (0%)	0	2/438 (0.5%)	2
Other (Not Including Serious) Adverse Events
	ORBIT II Subjects - 30 Day Results		ORBIT II Subjects - 1 Year Results
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	34/443 (7.7%)		0/438 (0%)
Surgical and medical procedures
Angiographic Complications	34/443 (7.7%)	34	0/438 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.