POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE

• Sponsor: Silk Road Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02536378
• Collaborator: (none)
• Enrollment: 692
• Locations: 43
• Actual Duration (Months): 42.2
• Patients Per Site: 16.1
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The ROADSTER 2 Study is intended to evaluate real world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System by physicians of varying experience with the transcarotid technique.

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Disease

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 692 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE. The ROADSTER 2 Study.
• Actual Study Start Date: Oct 23, 2015
• Actual Primary Completion Date: Apr 29, 2019
• Actual Study Completion Date: Apr 29, 2019

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Procedural Success [30 Days]

   Procedural success is defined as acute device success (successful insertion of the ENROUTE NPS and establishment of flow reversal), technical success (deployment of interventional tools) and the absence of a major adverse events (hierarchical stroke/death/myocardial infarction) through 30 days.

Secondary Outcome Measures

1. Number of Participants Experiencing Major Adverse Event [30 days]

   Secondary endpoints include the 30-day rate of hierarchical stroke, death or myocardial infarction, the rate of hierarchical stroke, death or myocardial infarction by symptom status, the rate of cardiac death and the rate of neurological death.

2. Number of Participants With Acute Device Success [2 hours (periprocedural)]

   Acute device success is defined as the ability to insert the device, establish flow reversal, and remove the device

3. Number of Participants With Technical Success [2 hours (periprocedural)]

   Technical success is defined as acute device success plus the ability to deliver interventional tools

4. Number of Participants in Which a Cranial Nerve Injury Occurred [90 days (extended follow-up)]

   Rate of cranial nerve injury suspected to be caused by surgical procedure and adjudicated by CEC.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

INCLUSION CRITERIA:

1. Patient must meet one of the following criteria regarding neurological symptom status and degree of stenosis:

Symptomatic: Stenosis must be >50% as determined by an angiogram and the patient has a history of stroke (minor or non-disabling; NIHSS ≤4 or mRS ≤2), TIA and/or amaurosis fugax within 180 days of the procedure procedure ipsilateral to the carotid artery to be stented.

OR Asymptomatic: Stenosis must be >80% as determined by angiogram without any neurological symptoms within the prior 180 days.

1. Target vessel must meet all requirements for ENROUTE Transcarotid Neuroprotection System and ENROUTE Stent System (refer to IFU for requirements).

2. Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).

3. Patient is ≥18 years of age.

4. Patient understands the nature of the procedure and has provided a signed informed consent using a form that has been reviewed and approved by the Institutional Review Board/Ethics Committee of the respective clinical site prior to the procedure. This will be obtained prior to participation in the study.

5. Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.

6. Patient must have a life expectancy ≥ 3 years at the time of the index procedure without contingencies related to other medical, surgical or endovascular intervention.

7. Patient meets at least one of the surgical high-risk criteria listed below.

Anatomic High Risk Inclusion Criteria:

1. Contralateral carotid artery occlusion B. Tandem stenoses >70% C. High cervical carotid artery stenosis D. Restenosis after carotid endarterectomy E. Bilateral carotid artery stenosis requiring treatment within 30 days after index treatment.

2. Hostile Necks which the Investigator deems safe for transcarotid access including but not limited to:

3. Prior neck irradiation II. Radical neck dissection III. Cervical spine immobility

Clinical High Risk Inclusion Criteria:

1. Patient is > 75 years of age H. Patient has > 2-vessel coronary artery disease and history of angina of any severity I. Patient has a history of angina

• Canadian Cardiovascular Society (CCS) angina class 3 or 4 or

• unstable angina

1. Patient has congestive heart failure (CHF) - New York Heart Association (NYHA)

• Functional Class III or IV

1. Patient has known severe left ventricular dysfunction

• LVEF <30%.

1. Patient has had a myocardial infarction > 72 hours and < 6 weeks prior to procedure.

M. Patient has severe pulmonary disease (COPD) with either:

• FEV1 <50% predicted or

• chronic oxygen therapy or

• resting PO2 of <60 mmHg (room air)

1. Patient has permanent contralateral cranial nerve injury O. Patient has chronic renal insufficiency (serum creatinine > 2.5 mg/dL).

REMINDER: The following is a list of anatomical considerations that are not suitable for transfemoral CAS with distal protection that are NOT contraindications for enrollment in the ROADSTER 2 Study including but not limited to:

1. TypeII, III, or Bovine arch II. Arch atheroma or calcification III. Atheroma of the great vessel origins IV. Tortuous distal ICA V. Tortuous or occluded iliofemoral segments
2. Occluded aortoiliac segments

EXCLUSION CRITERIA:

Each potential patient must be screened to ensure that they do not meet any of the following exclusion criteria. This screening is to be based on known medical history and data available at the time of eligibility determination and enrollment.

1. Patient has an alternative source of cerebral embolus, including but not limited to:

2. Patient has chronic atrial fibrillation.

3. Patient has had any episode of paroxysmal atrial fibrillation within the past 6 months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation.

4. Knowledge of cardiac sources of emboli. e.g. left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, aortic or mitral prosthetic heart valve, calcific aortic stenosis, endocarditis, mitral stenosis, atrial septal defect, atrial septal aneurysm, or left atrial myxoma).

5. Recently (<60 days) implanted heart valve (either surgically or endovascularly), which is a known source of emboli as confirmed on echocardiogram.

6. Abnormal angiographic findings: ipsilateral intracranial or extracranial arterial stenosis (as determined by angiography or CTA/MRA ≤ 6 months prior to index procedure) greater in severity than the lesion to be treated, cerebral aneurysm > 5 mm, AVM (arteriovenous malformation) of the cerebral vasculature, or other abnormal angiographic findings.

7. Patient has a history of spontaneous intracranial hemorrhage within the past 12 months, or has had a recent (<7 days) stroke of sufficient size (on CT or MRI) to place him or her at risk of hemorrhagic conversion during the procedure.

8. Patient had hemorrhagic transformation of an ischemic stroke within the past 60 days.

9. Patient with a history of major stroke attributable to either carotid artery (CVA or retinal embolus) with major neurological deficit (NIHSS ≥ 5 OR mRS ≥ 3) likely to confound study endpoints within 1 month of index procedure.

10. Patient has an intracranial tumor.

11. Patient has an evolving stroke.

12. Patient has neurologic illnesses within the past two years characterized by fleeting or fixed neurologic deficit which cannot be distinguished from TIA or stroke, including but not limited to: moderate to severe dementia, partial or secondarily generalized seizures, complicated or classic migraine, tumor or other space-occupying brain lesions, subdural hematoma, cerebral contusion or other post-traumatic lesions, intracranial infection, demyelinating disease, or intracranial hemorrhage).

13. Patient has had a TIA or amaurosis fugax within 48 hrs prior to the procedure.

14. Patient has an isolated hemisphere.

15. Patient had or will have CABG, endovascular stent procedure, valve intervention or vascular surgery within 30 days before or after the intervention.

16. Myocardial Infarction within 72 hours prior to the intervention.

17. Presence of a previous placed intravascular stent in target vessel or ipsilateral CCA or significant CCA inflow lesion.

18. Occlusion or [Thrombolysis In Myocardial Infarction Trial (TIMI 0)] "string sign" >1cm of the ipsilateral common or internal carotid artery.

19. An intraluminal filling defect (defined as an endoluminal lucency surrounded by contrast, seen in multiple angiographic projections, in the absence of angiographic evidence of calcification) whether or not it is associated with an ulcerated target lesion.

20. Ostium of Common Carotid Artery (CCA) requires revascularization.

21. Patient has an open stoma in the neck.

22. Female patients who are pregnant or may become pregnant.

23. Patient has history of intolerance or allergic reaction to any of the study medications or stent materials (refer to stent IFU), including aspirin (ASA), ticlopidine, clopidogrel, statin or contrast media (that can't be pre medicated). Patients must be able to tolerate statins and a combination of ASA and ticlopidine or ASA and clopidogrel.

24. Patient must have a life expectancy <3 years without contingencies related to other medical, surgical, or interventional procedures as per the Wallaert Score and patients with primary, recurrent or metastatic malignancy who do not have independent assessment of life expectancy performed by the treating oncologist or an appropriate specialist other than the physician performing TCAR.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peter Morton UCLA Medical Center	Los Angeles	California	United States	90095
2	MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010
3	Emory Healthcare	Atlanta	Georgia	United States	30322
4	Kaiser Permanente, Hawaii	Honolulu	Hawaii	United States	96819
5	Indiana University Health Methodist Hospital	Indianapolis	Indiana	United States	46202
6	Unity Point Health - Iowa Clinic	Des Moines	Iowa	United States	50309
7	Baptist Health Louisville	Louisville	Kentucky	United States	40207
8	Eastern Maine Medical Center	Bangor	Maine	United States	04401
9	John Hopkins	Baltimore	Maryland	United States	21224
10	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
11	Beth Israel	Boston	Massachusetts	United States	02215
12	St. Elizabeth's Medical Center	Brighton	Massachusetts	United States	02135
13	Michigan Vascular Center	Flint	Michigan	United States	48507
14	Abbott Northwestern	Minneapolis	Minnesota	United States	55407
15	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
16	Dartmouth Hitchcock Medical Ct.	Lebanon	New Hampshire	United States	03756
17	New Mexico	Albuquerque	New Mexico	United States	87102
18	Albany Medical Center	Albany	New York	United States	12208
19	Sisters of Charity Hospital	Buffalo	New York	United States	14214
20	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
21	Columbia University Medical Center	New York	New York	United States	10032
22	New Your Presbytarian - Weill Cornell	New York	New York	United States	10065
23	University of Rochester	Rochester	New York	United States	14623
24	Stony Brook Medicine	Stony Brook	New York	United States	11794
25	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina	United States	27599
26	Carolinas Medical Center	Charlotte	North Carolina	United States	28203
27	University Hospitals Case Medical Center and Case Western Reserve University School of Medicine	Cleveland	Ohio	United States	44106
28	Oklahoma Heart	Oklahoma City	Oklahoma	United States	73120
29	St. Luke's University Health Network	Bethlehem	Pennsylvania	United States	18018
30	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
31	UPMC (University of Pittsburgh Medical Center)	Pittsburgh	Pennsylvania	United States	15213
32	Greenville Hospital System	Greenville	South Carolina	United States	29605
33	Wellmont CVA Heart Institute	Kingsport	Tennessee	United States	37660
34	Cardiothoracic and Vascular Surgeons	Austin	Texas	United States	78756
35	Houston Methodist DeBakey Heart & Vascular Center	Houston	Texas	United States	77030
36	Michael E DeBakey VA Medical Center	Houston	Texas	United States	77030
37	Scott and White Memorial Hospital	Temple	Texas	United States	76508
38	Sentara Vascular Specialists	Chesapeake	Virginia	United States	23320
39	Virginia Mason Medical Center	Seattle	Washington	United States	98101
40	CAMC Clinical Trials Center	Charleston	West Virginia	United States	25304
41	University of Wisconsin	Madison	Wisconsin	United States	53792
42	Technical University Munich	Munich		Germany	81675
43	Hospital Quirónsalud Marbella	Marbella		Spain	29603

Sponsors and Collaborators

• Silk Road Medical

Investigators

• Principal Investigator: Vikram Kashyap, MD, University Hospital Case Medical Center Harrington Heart & Vascular Institute
• Principal Investigator: Peter Schneider, MD, Kaiser Permanente, Hawaii

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 10, 2017

More Information

Additional Information:

• Transcarotid Artery Revascularization With Flow Reversal: The PROOF Study

Publications

None provided.

• Responsible Party: Silk Road Medical
• ClinicalTrials.gov Identifier: NCT02536378
• Other Study ID Numbers: SRM-2015-02
• First Posted: Aug 31, 2015
• Last Update Posted: Jul 29, 2020
• Last Verified: Jul 1, 2020

• Additional relevant MeSH terms: Carotid Artery Diseases

Study Results

Participant Flow

Arm/Group Title	PP (Per Protocol)	ITT (Intention to Treat)
Arm/Group Description	Patients who underwent the study procedure, independent of the success of the procedure and in the absence of major protocol deviations. The analysis of the PP population excludes those subjects for whom a major protocol deviation was identified by the CEC	All patients who were enrolled in the pivotal phase of the study but had major protocol deviations
Period Title: Overall Study
STARTED	632	60
COMPLETED	625	53
NOT COMPLETED	7	7

Baseline Characteristics

Arm/Group Title	PP (Per Protocol)	ITT (Intention to Treat)	Total
Arm/Group Description	Patients who underwent the study procedure, independent of the success of the procedure and in the absence of major protocol deviations. The analysis of the PP population excludes those subjects for whom a major protocol deviation was identified by the CEC	Patients who were enrolled in the pivotal phase of the study but had a major protocol deviation are included	Total of all reporting groups
Overall Participants	632	60	692
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	104 16.5%	9 15%	113 16.3%
>=65 years	528 83.5%	51 85%	579 83.7%
Sex: Female, Male (Count of Participants)
Female	204 32.3%	19 31.7%	223 32.2%
Male	428 67.7%	41 68.3%	469 67.8%
Race/Ethnicity, Customized (Count of Participants)
African American	28 4.4%	7 11.7%	35 5.1%
Asian	5 0.8%	2 3.3%	7 1%
Caucasian	560 88.6%	45 75%	605 87.4%
Hispanic or Latino	23 3.6%	5 8.3%	28 4%
Pacific Islander	3 0.5%	0 0%	3 0.4%
Unknown/Other	11 1.7%	1 1.7%	12 1.7%
Mixed Race	2 0.3%	0 0%	2 0.3%
Symptomatic Status (Count of Participants)
Asymptomatic	466 73.7%	46 76.7%	512 74%
Symptomatic	166 26.3%	14 23.3%	180 26%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	170.3 (9.91)	169.0 (11.8)	170.2 (9.93)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	81.5 (18.23)	83.6 (18.72)	81.7 (18.48)
High Surgical Risk Inclusion Criteria - Anatomic Risk Factors (Count of Participants)
Yes	64 10.1%	3 5%	67 9.7%
No	568 89.9%	57 95%	625 90.3%
Yes	10 1.6%	3 5%	13 1.9%
No	622 98.4%	57 95%	679 98.1%
Yes	177 28%	18 30%	195 28.2%
No	455 72%	42 70%	497 71.8%
Yes	122 19.3%	13 21.7%	135 19.5%
No	510 80.7%	47 78.3%	557 80.5%
Yes	52 8.2%	1 1.7%	53 7.7%
No	580 91.8%	59 98.3%	639 92.3%
Yes	24 3.8%	2 3.3%	26 3.8%
No	608 96.2%	58 96.7%	666 96.2%
Medical History (Percentage of participants) [Number]
Symptomatic	26.3 4.2%	23.3 38.8%	26 3.8%
Male	67.7 10.7%	68.3 113.8%	67.8 9.8%
Diabetes	35 5.5%	46.7 77.8%	36 5.2%
Hypertension	90.3 14.3%	95.0 158.3%	90.8 13.1%
History of Peripheral Artery Disease	24.7 3.9%	30.0 50%	25.1 3.6%
History of Coronary Artery Disease	14.6 2.3%	10.0 16.7%	14.2 2.1%
History of Angina	2.1 0.3%	0.0 0%	1.9 0.3%
Congestive Heart Failure	1.9 0.3%	0.0 0%	1.7 0.2%
Recent MI	0.8 0.1%	0.0 0%	0.7 0.1%
Severe Pulmonary Disease	2.8 0.4%	1.7 2.8%	2.7 0.4%
Dyslipidemia	85.8 13.6%	91.7 152.8%	86.3 12.5%
History of Stroke	15.7 2.5%	23.3 38.8%	16.4 2.4%
History of TIA	16.1 2.5%	15.0 25%	16.0 2.3%
History of Amaurosis Fugax	8.5 1.3%	8.3 13.8%	8.5 1.2%
Current Nicotine Use	21.8 3.4%	13.3 22.2%	21.1 3%
Age ≥75 Years	41.8 6.6%	45.0 75%	42.1 6.1%
Age ≥80 Years	21.2 3.4%	20.0 33.3%	21.1 3%
Contralateral Carotid Occlusion	10.1 1.6%	5.0 8.3%	9.7 1.4%
High Cervical Carotid Stenosis	28 4.4%	30.0 50%	28.2 4.1%
Restenosis after CEA	19.3 3.1%	21.7 36.2%	19.5 2.8%
Bilateral Stenosis Requiring Treatment	8.2 1.3%	1.7 2.8%	7.7 1.1%
Hostile Neck Safe for Transcarotid Access	3.8 0.6%	3.3 5.5%	3.8 0.5%
>2 Vessel Coronary Disease	14.6 2.3%	10.0 16.7%	14.2 2.1%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Procedural Success
Description	Procedural success is defined as acute device success (successful insertion of the ENROUTE NPS and establishment of flow reversal), technical success (deployment of interventional tools) and the absence of a major adverse events (hierarchical stroke/death/myocardial infarction) through 30 days.
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PP (Per Protocol)	ITT (Intention to Treat)
Arm/Group Description	Patients who underwent the study procedure, independent of the success of the procedure and in the absence of major protocol deviations. The analysis of the PP population excludes those subjects for whom a major protocol deviation was identified by the CEC	All patients who were enrolled in the pivotal phase of the study, including patients with major protocol deviations
Measure Participants	632	692
Count of Participants [Participants]	630 99.7%	690 1150%

2. Secondary Outcome

Title	Number of Participants Experiencing Major Adverse Event
Description	Secondary endpoints include the 30-day rate of hierarchical stroke, death or myocardial infarction, the rate of hierarchical stroke, death or myocardial infarction by symptom status, the rate of cardiac death and the rate of neurological death.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

30 day Major Adverse Events as adjudicated by CEC

Arm/Group Title	PP (Per Protocol)	ITT (Intention to Treat)
Arm/Group Description	Patients who underwent the study procedure, independent of the success of the procedure and in the absence of major protocol deviations. The analysis of the PP population excludes those subjects for whom a major protocol deviation was identified by the CEC.	All patients who were enrolled in the pivotal phase of the study, including patients with major protocol deviations
Measure Participants	632	692
Death	1	3
Stroke	4	13
Myocardial Infarction	6	6

3. Secondary Outcome

Title	Number of Participants With Acute Device Success
Description	Acute device success is defined as the ability to insert the device, establish flow reversal, and remove the device
Time Frame	2 hours (periprocedural)

Outcome Measure Data

Analysis Population Description

2 enrolled patients were withdrawn by the Investigator

Arm/Group Title	PP (Per Protocol)	ITT (Intention to Treat)
Arm/Group Description	Patients who underwent the study procedure, independent of the success of the procedure and in the absence of major protocol deviations. The analysis of the PP population excludes those subjects for whom a major protocol deviation was identified by the CEC	All patients who were enrolled in the pivotal phase of the study in which a major protocol deviation was identified by the CEC.
Measure Participants	632	692
Count of Participants [Participants]	630 99.7%	690 1150%

4. Secondary Outcome

Title	Number of Participants With Technical Success
Description	Technical success is defined as acute device success plus the ability to deliver interventional tools
Time Frame	2 hours (periprocedural)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PP (Per Protocol)	ITT (Intention to Treat)
Arm/Group Description	Patients who underwent the study procedure, independent of the success of the procedure and in the absence of major protocol deviations. The analysis of the PP population excludes those subjects for whom a major protocol deviation was identified by the CEC.	All patients who were enrolled in the pivotal phase of the study, including patients with major protocol deviations
Measure Participants	632	692
Count of Participants [Participants]	630 99.7%	690 1150%

5. Secondary Outcome

Title	Number of Participants in Which a Cranial Nerve Injury Occurred
Description	Rate of cranial nerve injury suspected to be caused by surgical procedure and adjudicated by CEC.
Time Frame	90 days (extended follow-up)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PP (Per Protocol)	ITT (Intention to Treat)
Arm/Group Description	Patients who underwent the study procedure, independent of the success of the procedure and in the absence of major protocol deviations. The analysis of the PP population excludes those subjects for whom a major protocol deviation was identified by the CEC.	All patients who were enrolled in the pivotal phase of the study, including patients with major protocol deviations
Measure Participants	632	692
Count of Participants [Participants]	8 1.3%	10 16.7%

Adverse Events

Time Frame	Adverse events were collected throughout the life of the study: 3 years, 6 months
Adverse Event Reporting Description	Major adverse events, cranial nerve injuries, device related, and unanticipated adverse device effect event data were collected through 30 day follow-up period and recorded on the Adverse Event CRF. The Investigator or Coordinator determined whether an adverse event occurred Major Adverse Events were defined in this study as stroke, death, or myocardial infarction as adjudicated by Clinical Events Committee. Other Adverse Events (non-serious) were not collected or assessed for this study
Arm/Group Title	PP (Per Protocol)		ITT (Intention to Treat)
Arm/Group Description	Patients who underwent the study procedure, independent of the success of the procedure and in the absence of major protocol deviations. The analysis of the PP population excludes those subjects for whom a major protocol deviation was identified by the CEC		All patients who were enrolled in the pivotal phase of the study in which a major protocol deviation was identified by the CEC.
All Cause Mortality
	PP (Per Protocol)		ITT (Intention to Treat)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/632 (0.2%)		3/692 (0.4%)
Serious Adverse Events
	PP (Per Protocol)		ITT (Intention to Treat)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	27/632 (4.3%)		14/692 (2%)
Cardiac disorders
Myocardial Infarction	6/632 (0.9%)	6	7/692 (1%)	7
General disorders
Death - Other	1/632 (0.2%)	1	1/692 (0.1%)	1
Musculoskeletal and connective tissue disorders
Cranial Nerve Injury	8/632 (1.3%)	8	10/692 (1.4%)	10
Nervous system disorders
Death - Neurological	0/632 (0%)	0	2/692 (0.3%)	2
Stroke - Contralateral	1/632 (0.2%)	1	1/692 (0.1%)	1
Stroke - Ipsilateral	3/632 (0.5%)	3	14/692 (2%)	14
Surgical and medical procedures
NPS Device Related Event	2/632 (0.3%)	2	2/692 (0.3%)	2
Possibly NPS/Stent device related event	5/632 (0.8%)	5	7/692 (1%)	7
Stent Device Related Event	1/632 (0.2%)	1	1/692 (0.1%)	1
Other (Not Including Serious) Adverse Events
	PP (Per Protocol)		ITT (Intention to Treat)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT 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.