ION US Post-Approval Study

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01422889
• Collaborator: (none)
• Enrollment: 1,120
• Locations: 40
• Duration (Months): 41
• Patients Per Site: 28
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The purpose of this study is to compile real-world clinical outcomes data for the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System in routine clinical practice.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis; Coronary Artery Disease	Device: ION™ Coronary Stent System

Detailed Description

The ION™ stent is the third-generation Boston Scientific (BSC) paclitaxel-eluting coronary stent. It is designed for improved performance specific to deliverability and radio-opacity while maintaining a similar drug release profile of the TAXUS Express and TAXUS Liberté stents. Following PMA approval from the FDA for the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System the ION US Post-Approval study will compile real-world clinical outcomes data for the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System in routine clinical practice. Post-approval studies of drug-eluting stents (DES) provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting.

Study Design

• Study Type: Observational
• Actual Enrollment: 1120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A U.S. Post-Approval Study of the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
ION Registry The ION Registry population was designed to collect real world safety and clinical outcomes data. There were 1120 subjects were enrolled, however 9 subjects did not receive a study stent therefore 1111 subjects were eligible for follow up.	Device: ION™ Coronary Stent System; This study is intended to evaluate the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System across a range of institutions and physician users to observe and assess subject outcomes and technology performance in a real-world setting.

Outcome Measures

Primary Outcome Measures

1. Cardiac Death or Myocardial Infarction (CD/MI) [12 Months]

   Cardiac Death or myocardial infarction (CD/MI) in the ION registry population. For the protocol specified primary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.

Secondary Outcome Measures

1. Stent Thrombosis [Annually, after the first year, through 2 years.]

   Academic Research Consortium (ARC) defined (definite/probable) stent thrombosis (ST) in the ION registry population. For the protocol specified secondary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 110 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Consented subjects receiving one or more ION(TM)Coronary Stents

Exclusion Criteria:

Subjects not clinically indicated to receive an ION (TM)Coronary Stent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NEA Baptist Memorial Hospital	Jonesboro	Arkansas	United States	72401
2	St. Bernard's Medical Center	Jonesboro	Arkansas	United States	72401
3	Bakersfield Memorial Hospital	Bakersfield	California	United States	93301
4	Alvarado Hospital	San Diego	California	United States	92121
5	Northside Hospital and Heart Institute	St. Petersburg	Florida	United States	33709
6	University Community Hospital	Tampa	Florida	United States	33613
7	Redmond Regional Medical Center	Rome	Georgia	United States	30165
8	Kootenai Medical Center	Coeur d'Alene	Idaho	United States	83814
9	Krannert Institute of Cardiology	Indianapolis	Indiana	United States	46202
10	Indiana Heart Hospital	Indianapolis	Indiana	United States	46250
11	Iowa Heart Center	West Des Moines	Iowa	United States	50266
12	King's Daughters Medical Center - Kentucky Heart Inst	Ashland	Kentucky	United States	41101
13	Maine Medical Center	Portland	Maine	United States	04102
14	Union Memorial Hospital	Baltimore	Maryland	United States	21218
15	Tufts Medical Center	Boston	Massachusetts	United States	02111
16	Sparrow Health System - Sparrow Hospital	Lansing	Michigan	United States	48910
17	Northern Michigan Hospital	Petoskey	Michigan	United States	49770
18	Lakeland Hospitals at St. Joseph	St. Joseph	Michigan	United States	49085
19	Memorial Hospital at Gulfport	Gulfport	Mississippi	United States	39501
20	Freeman West Hospital	Joplin	Missouri	United States	64804
21	Our Lady of Lourdes Medical Center	Haddon Heights	New Jersey	United States	08035
22	Jersey Shore University Medical Center	Sea Girt	New Jersey	United States	08750
23	St. Joseph's Hospital Health Center	Liverpool	New York	United States	13088
24	St. Elizabeth Medical Center	Utica	New York	United States	13501
25	Wake Medical Center	Raleigh	North Carolina	United States	27610
26	Ohio State University Medical Center	Columbus	Ohio	United States	43210
27	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
28	Mercy St. Vincent Medical Center	Toledo	Ohio	United States	43608
29	Oklahoma Heart Hospital	Oklahoma City	Oklahoma	United States	73120
30	St. Mary Medical Center	Yardley	Pennsylvania	United States	19067
31	Sisters of Charity Providence Hospital	Columbia	South Carolina	United States	29204
32	Grand Strand Regional Medical Center	Myrtle Beach	South Carolina	United States	29572
33	Regional Hospital	Jackson	Tennessee	United States	38305
34	Centennial Medical Center	Nashville	Tennessee	United States	37203
35	Baylor Heart & Vascular Hospital	Dallas	Texas	United States	75226
36	CRSTI/Medical City Dallas	Dallas	Texas	United States	75230
37	Kingwood Medical Center Hospital	Kingwood	Texas	United States	77339
38	Methodist Texsan Hospital	San Antonio	Texas	United States	78201
39	Meriter Hospital, Inc.	Madison	Wisconsin	United States	53713
40	CaRE Foundation, Inc.	Wausau	Wisconsin	United States	54401

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Louis A Cannon, MD, Northern Michigan Hospital
• Principal Investigator: Carey D Kimmelstiel, MD, Tufts Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT01422889
• Other Study ID Numbers: S2065
• First Posted: Aug 25, 2011
• Last Update Posted: Feb 4, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Boston Scientific Corporation: Atherosclerosis; Coronary Artery Disease
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Atherosclerosis

Study Results

Participant Flow

Recruitment Details	Subject recruitment began on 19 September 2011 and was completed on 24 April 2012.

Arm/Group Title	ION Registry
Arm/Group Description	The ION Registry population consists of 1111 subjects that were enrolled and received a study stent.
Period Title: Overall Study
STARTED	1120
COMPLETED	1111
NOT COMPLETED	9

Baseline Characteristics

Arm/Group Title	ION Registry
Arm/Group Description	The ION Registry population contains 1120 enrolled subjects with 1111 eligible for analysis. Subjects eligible for analysis includes subjects with at least one study stent implanted.
Overall Participants	1111
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.1 (10.98)
Sex: Female, Male (Count of Participants)
Female	330 29.7%
Male	781 70.3%
Region of Enrollment (participants) [Number]
United States	1111 100%
Cardiac Risk Factors (participants) [Number]
Diabetes	376 33.8%
Current Smoker	275 24.8%
Hypertension	905 81.5%
Hyperlipidemia	869 78.2%
Unstable Angina	485 43.7%
Prior PCI	522 47%
Lesion Characteristics (participants) [Number]
RVD<=2.5mm	387 34.8%
Long Lesions (>=28mm)	235 21.2%
Bifurcation	116 10.4%
Lesion Characteristics:Lesion Based (Lesions) [Number]
Culprit for STEMI	108
Severe Calcification	79

Outcome Measures

1. Primary Outcome

Title	Cardiac Death or Myocardial Infarction (CD/MI)
Description	Cardiac Death or myocardial infarction (CD/MI) in the ION registry population. For the protocol specified primary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

There were 83 subjects not evaluable for 12-month cardiac events (No follow-up ≥ 335 days and events-free within 365-day) leaving a total of 1028 subjects evaluated for 12 month CD/MI.

Arm/Group Title	ION Registry
Arm/Group Description	The ION Registry includes the 1111 enrolled subjects that received a study stent.
Measure Participants	1028
Number [percentage of paricipants]	2.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ION Registry
	Comments	2.2% (23/1028) of ION Registry subjects experienced CD/MI related to the ION stent at 12 months
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percentage
	Estimated Value	2.2
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Stent Thrombosis
Description	Academic Research Consortium (ARC) defined (definite/probable) stent thrombosis (ST) in the ION registry population. For the protocol specified secondary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations.
Time Frame	Annually, after the first year, through 2 years.

Outcome Measure Data

Analysis Population Description

There were 57 subjects not evaluable for 2-year cardiac events (No follow-up ≥ 700 days and events-free within 730-day) leaving a total of 1054 subjects evaluated for ARC ST Definite/Probable.

Arm/Group Title	ION Registry
Arm/Group Description	The ION Registry includes the 1111 enrolled subjects that received a study stent.
Measure Participants	1054
Number [percentage of participants]	2.6 0.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ION Registry
	Comments	2.6% (27/1054) of ION Registry subjects experienced ARC ST Definite/Probable related to the ION stent at 2 years.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percentage
	Estimated Value	2.6
	Confidence Interval	(1-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	1 year
Arm/Group Title	ION Registry
Arm/Group Description	The ION Registry population will contain the first 1115 consecutive, consenting patients
All Cause Mortality
	ION Registry
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	ION Registry
	Affected / at Risk (%)	# Events
Total	324/1111 (29.2%)
Blood and lymphatic system disorders
Anaemia	14/1111 (1.3%)	17
Haemorrhagic anaemia	2/1111 (0.2%)	2
Heparin-induced thrombocytopenia	1/1111 (0.1%)	1
Thrombocytopenia	1/1111 (0.1%)	1
Cardiac disorders
Angina Pectoris	59/1111 (5.3%)	70
Angina Unstable	23/1111 (2.1%)	31
Acute Myocardial Infarction	27/1111 (2.4%)	27
Cardiac Congestive Failure	23/1111 (2.1%)	26
Coronary artery thrombosis	15/1111 (1.4%)	18
Myocardial Infarction	17/1111 (1.5%)	17
Atrial Fibriliation	14/1111 (1.3%)	17
Coronary artery disease	13/1111 (1.2%)	14
Cardiac arrest	7/1111 (0.6%)	7
Acute Coronary System	5/1111 (0.5%)	5
Cardiac failure	4/1111 (0.4%)	4
Coronary artery stenosis	4/1111 (0.4%)	4
Ventricular fibrillation	4/1111 (0.4%)	4
Atrial flutter	3/1111 (0.3%)	4
Cardiac failure chronic	3/1111 (0.3%)	4
Cardiogenic shock	3/1111 (0.3%)	4
Ischaemic cardiomyopathy	3/1111 (0.3%)	4
Ventricular tachycardia	2/1111 (0.2%)	4
Cardiomyopathy	3/1111 (0.3%)	3
Arrhythmia supraventricular	2/1111 (0.2%)	2
Atrioventricular block	2/1111 (0.2%)	2
Coronary artery dissection	2/1111 (0.2%)	2
Pericarditis	2/1111 (0.2%)	2
Sick sinus syndrome	2/1111 (0.2%)	2
Atrial tachycardia	1/1111 (0.1%)	1
Atrioventricular block	1/1111 (0.1%)	1
Bradycardia	1/1111 (0.1%)	1
Cardiac tamponade	1/1111 (0.1%)	1
Cardio-respiratory arrest	1/1111 (0.1%)	1
Cardiopulmonary failure	1/1111 (0.1%)	1
Chronotropic incompetence	1/1111 (0.1%)	1
Intracardiac thrombus	1/1111 (0.1%)	1
Mitral valve incompetence	1/1111 (0.1%)	1
Myocardial ischaemia	1/1111 (0.1%)	1
Palpitations	1/1111 (0.1%)	1
Pericardial effusion	1/1111 (0.1%)	1
Sinus arrest	1/1111 (0.1%)	1
Tachycardia	1/1111 (0.1%)	1
Congenital, familial and genetic disorders
Arteriovenous malformation	1/1111 (0.1%)	1
Congenital coronary artery malformation	1/1111 (0.1%)	1
Ear and labyrinth disorders
Vertigo	1/1111 (0.1%)	1
Endocrine disorders
Hyperthyroidism	1/1111 (0.1%)	1
Eye disorders
Cataract	2/1111 (0.2%)	2
Conjunctival haemorrhage	1/1111 (0.1%)	1
Vision blurred	1/1111 (0.1%)	1
Gastrointestinal disorders
Gastrointestinal haemorrhage	11/1111 (1%)	12
Small intestinal obstruction	3/1111 (0.3%)	3
Abdominal pain	2/1111 (0.2%)	2
Colonic polyp	2/1111 (0.2%)	2
Constipation	2/1111 (0.2%)	2
Pancreatitis	2/1111 (0.2%)	2
Retroperitoneal haemorrhage	2/1111 (0.2%)	2
Diarrhoea	1/1111 (0.1%)	2
Abdominal pain upper	1/1111 (0.1%)	1
Ascites	1/1111 (0.1%)	1
Barrett's oesophagus	1/1111 (0.1%)	1
Colitis ischaemic	1/1111 (0.1%)	1
Duodenal ulcer	1/1111 (0.1%)	1
Enterovesical fistula	1/1111 (0.1%)	1
Epiploic appendagitis	1/1111 (0.1%)	1
Gastritis	1/1111 (0.1%)	1
Gastrointestinal ulcer haemorrhage	1/1111 (0.1%)	1
Gastroesophageal reflux disease	1/1111 (0.1%)	1
Ileus	1/1111 (0.1%)	1
Inguinal hernia	1/1111 (0.1%)	1
Intestional perforation	1/1111 (0.1%)	1
Intra-abdominal haemorrhage	1/1111 (0.1%)	1
Lower gastrointestinal haemorrhage	1/1111 (0.1%)	1
Pancreatitis acute	1/1111 (0.1%)	1
Pancreatitis chronic	1/1111 (0.1%)	1
Rectal haemorrhage	1/1111 (0.1%)	1
Retroperitoneal haematoma	1/1111 (0.1%)	1
Upper gastrointestinal haemorrhage	1/1111 (0.1%)	1
General disorders
Non-cardiac chest pain	35/1111 (3.2%)	46
Chest pain	6/1111 (0.5%)	6
Chest discomfort	3/1111 (0.3%)	3
Pyrexia	3/1111 (0.3%)	3
Asthenia	1/1111 (0.1%)	1
Catheter site haematoma	1/1111 (0.1%)	1
Hernia obstructive	1/1111 (0.1%)	1
Sudden cardiac death	1/1111 (0.1%)	1
Hepatobiliary disorders
Biliary dyskinesia	1/1111 (0.1%)	1
Cholelithiasis	1/1111 (0.1%)	1
Hepatic artery stenosis	1/1111 (0.1%)	1
Hepatic cirrhosis	1/1111 (0.1%)	1
Hepatic congestion	1/1111 (0.1%)	1
Ischaemic hepatitis	1/1111 (0.1%)	1
Infections and infestations
Pneumonia	18/1111 (1.6%)	22
Urinary tract infection	10/1111 (0.9%)	10
Sepsis	5/1111 (0.5%)	5
Diverticulitis	4/1111 (0.4%)	5
Bronchitis	3/1111 (0.3%)	3
Cellulitis	3/1111 (0.3%)	3
Abscess	2/1111 (0.2%)	2
Appendicitis	2/1111 (0.2%)	2
Gastroenteritis	2/1111 (0.2%)	2
Arthritis bacterial	1/1111 (0.1%)	1
Bacteraemia	1/1111 (0.1%)	1
Gangrene	1/1111 (0.1%)	1
Gastroenteritis viral	1/1111 (0.1%)	1
Herpes zoster	1/1111 (0.1%)	1
Infected skin ulcer	1/1111 (0.1%)	1
Lobar pneumonia	1/1111 (0.1%)	1
Meningitis	1/1111 (0.1%)	1
Osteomyelitis acute	1/1111 (0.1%)	1
Periorbital abscess	1/1111 (0.1%)	1
Peritonitis bacterial	1/1111 (0.1%)	1
Pneumonia influenzal	1/1111 (0.1%)	1
Pneumonia pneumococcal	1/1111 (0.1%)	1
Postoperative wound infection	1/1111 (0.1%)	1
Pyelonephritis	1/1111 (0.1%)	1
Septic shock	1/1111 (0.1%)	1
Tooth infection	1/1111 (0.1%)	1
Injury, poisoning and procedural complications
Post procedural myocardial infarction	2/1111 (0.2%)	2
Tibia fracture	2/1111 (0.2%)	2
Vascular pseudoaneurysm	2/1111 (0.2%)	2
Anaemia postoperative	1/1111 (0.1%)	1
Arterial injury	1/1111 (0.1%)	1
Device malfunction	1/1111 (0.1%)	1
Hip fracture	1/1111 (0.1%)	1
Lower limb fracture	1/1111 (0.1%)	1
Post procedural haematoma	1/1111 (0.1%)	1
Postoperative ileus	1/1111 (0.1%)	1
Renal injury	1/1111 (0.1%)	1
Subdural haematoma	1/1111 (0.1%)	1
Investigations
Cardiac stress test abnormal	2/1111 (0.2%)	2
Blood creatinine increased	1/1111 (0.1%)	1
Heart rate increased	1/1111 (0.1%)	1
International normalized ratio increased	1/1111 (0.1%)	1
Metabolism and nutrition disorders
Dehydration	7/1111 (0.6%)	7
Diabetes mellitus inadequate control	2/1111 (0.2%)	2
Hyperglycaemia	2/1111 (0.2%)	2
Hypokalaemia	2/1111 (0.2%)	2
Electrolyte imbalance	1/1111 (0.1%)	1
Failure to thrive	1/1111 (0.1%)	1
Hypervolaemia	1/1111 (0.1%)	1
Hyponatraemia	1/1111 (0.1%)	1
Musculoskeletal and connective tissue disorders
Intervertebral disc protusion	1/1111 (0.1%)	1
Lumbar spinal stenosis	1/1111 (0.1%)	1
Muscle spasms	1/1111 (0.1%)	1
Osteoarthritis	1/1111 (0.1%)	1
Pain in extremity	1/1111 (0.1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	1/1111 (0.1%)	1
Breast cancer metastatic	1/1111 (0.1%)	1
Bronchial carcinoma	1/1111 (0.1%)	1
Colon cancer metastatic	1/1111 (0.1%)	1
Endometrial cancer	1/1111 (0.1%)	1
Lung adenocarcinoma stage IV	1/1111 (0.1%)	1
Lung neoplasm malignant	1/1111 (0.1%)	1
Metastatic neoplasm	1/1111 (0.1%)	1
Parathyroid tumour benign	1/1111 (0.1%)	1
Small cell lung cancer stage unspecified	1/1111 (0.1%)	1
Vaginal cancer	1/1111 (0.1%)	1
Nervous system disorders
Syncope	8/1111 (0.7%)	8
Cerebrovascular accident	6/1111 (0.5%)	6
Carotid artery stenosis	2/1111 (0.2%)	2
Transient ischaemic attack	2/1111 (0.2%)	2
Ataxia	1/1111 (0.1%)	1
Cerebral haemorrhage	1/1111 (0.1%)	1
Embolic stroke	1/1111 (0.1%)	1
Hemiparesis	1/1111 (0.1%)	1
Ischaemic stroke	1/1111 (0.1%)	1
Migrane	1/1111 (0.1%)	1
Neuropathy peripheral	1/1111 (0.1%)	1
Presyncope	1/1111 (0.1%)	1
Subarachnoid haemorrhage	1/1111 (0.1%)	1
Psychiatric disorders
Bipolar I disorder	1/1111 (0.1%)	1
Deperession	1/1111 (0.1%)	1
Suicidal ideation	1/1111 (0.1%)	1
Renal and urinary disorders
Renal failure	4/1111 (0.4%)	4
Renal failure acute	3/1111 (0.3%)	3
Renal failure chronic	3/1111 (0.3%)	3
Nephrolithiasis	1/1111 (0.1%)	1
Nephropathy toxic	1/1111 (0.1%)	1
Renal disorder	1/1111 (0.1%)	1
Renal impairment	1/1111 (0.1%)	1
Ureteric obstruction	1/1111 (0.1%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea	8/1111 (0.7%)	8
Chronic obstructive pulmonary disease	6/1111 (0.5%)	8
Pleural effusion	4/1111 (0.4%)	4
Pulmonary embolism	4/1111 (0.4%)	4
Respiratory failure	4/1111 (0.4%)	4
Acute respiratory failure	2/1111 (0.2%)	2
Epistaxis	2/1111 (0.2%)	2
Pulmonary oedema	2/1111 (0.2%)	2
Acute pulmonary oedema	1/1111 (0.1%)	1
Pleuritic pain	1/1111 (0.1%)	1
Pneumothorax	1/1111 (0.1%)	1
Respiratory arrest	1/1111 (0.1%)	1
Respiratory distress	1/1111 (0.1%)	1
Skin and subcutaneous tissue disorders
Ecchymosis	1/1111 (0.1%)	1
Rash	1/1111 (0.1%)	1
Skin plaque	1/1111 (0.1%)	1
Skin ulcer	1/1111 (0.1%)	1
Surgical and medical procedures
Cardiac pacemaker battery replacement	1/1111 (0.1%)	1
Vascular disorders
Hypertension	4/1111 (0.4%)	6
Peripheral vascular disorder	4/1111 (0.4%)	5
Aortic stenosis	2/1111 (0.2%)	2
Deep vein thrombosis	2/1111 (0.2%)	2
Femoral arterial stenosis	2/1111 (0.2%)	2
Intermittent claudication	2/1111 (0.2%)	2
Aortic aneurysm	1/1111 (0.1%)	1
Arterial haemorrhage	1/1111 (0.1%)	1
Haemorrhage	1/1111 (0.1%)	1
Hypotension	1/1111 (0.1%)	1
Iliac artery embolism	1/1111 (0.1%)	1
Iliac artery occlusion	1/1111 (0.1%)	1
Leriche syndrome	1/1111 (0.1%)	1
Orthostatic hypotension	1/1111 (0.1%)	1
Peripheral ischaemia	1/1111 (0.1%)	1
Other (Not Including Serious) Adverse Events
	ION Registry
	Affected / at Risk (%)	# Events
Total	0/1111 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.