Zenith® Dissection Clinical Trial

• Sponsor: Cook Research Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01568320
• Collaborator: (none)
• Enrollment: 73
• Locations: 24
• Arm: 1
• Actual Duration (Months): 89.9
• Patients Per Site: 3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The Zenith® Dissection Clinical Trial is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of acute, complicate Type B aortic dissection.

Condition or Disease	Intervention/Treatment	Phase
Aortic Dissection	Device: Endovascular Treatment (Zenith)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 73 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Use of the Zenith® Dissection Endovascular System in the Treatment of Patients With Acute, Complicated Type B Aortic Dissection
• Actual Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Jan 27, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Endovascular Endovascular Treatment (Zenith)	Device: Endovascular Treatment (Zenith); Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.; Other Names: Endovascular graft Endovascular stent Stent-graft

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Freedom From Major Adverse Events [30 days]

   Primary safety : Major adverse events include: myocardial infarction, chronic renal insufficiency/chronic renal failure requiring dialysis, bowel ischemia, stroke, paraplegia or paraparesis, and prolonged ventilator support

2. Survival Rate at 30 Days [30 days]

   Primary effectiveness endpoint is freedom from all cause mortality at 30 days

Eligibility Criteria

Criteria

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

Exclusion Criteria:

1. Age < 18 years;

2. Other medical condition (e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the Clinical Investigation Plan, confound the results, or is associated with limited life expectancy (i.e., less than 2 years);

3. Pregnant, breast-feeding, or planning on becoming pregnant within 60 months;

4. Unwilling or unable to comply with the follow-up schedule;

5. Inability or refusal to give informed consent;

6. Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.);

7. Additional medical restrictions as specified in the Clinical Investigation Plan; or

8. Additional anatomical restrictions as specified in the Clinical Investigation Plan.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
2	University of Florida	Gainesville	Florida	United States	32610
3	University of South Florida	Tampa	Florida	United States	33606
4	Indiana Heart Hospital	Indianapolis	Indiana	United States	46250
5	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
6	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
7	University of Massachusetts	Worcester	Massachusetts	United States	01655
8	University of Michigan Hospital	Ann Arbor	Michigan	United States	48109
9	Barnes-Jewish Hospital	Saint Louis	Missouri	United States	63110
10	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
11	Cooper University Hospital	Camden	New Jersey	United States	08103
12	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
13	New York University Hospital	New York	New York	United States	10016
14	Duke University Medical Center	Durham	North Carolina	United States	27710
15	The Christ Hospital	Cincinnati	Ohio	United States	45219
16	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
17	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212
18	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
19	The Methodist Hospital	Houston	Texas	United States	77030
20	Scott and White Hospital	Temple	Texas	United States	76508
21	University of Virginia Medical Center	Charlottesville	Virginia	United States	22908
22	Sentara Vascular Specialists	Norfolk	Virginia	United States	23507
23	University of Washington-Harborview Medical Center	Seattle	Washington	United States	98104
24	Jikei University School of Medicine	Tokyo		Japan

Sponsors and Collaborators

• Cook Research Incorporated

Investigators

• Principal Investigator: Joseph Lombardi, MD, The Cooper Health System

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 28, 2018

More Information

Publications

None provided.

• Responsible Party: Cook Research Incorporated
• ClinicalTrials.gov Identifier: NCT01568320
• Other Study ID Numbers: 11-007
• First Posted: Apr 2, 2012
• Last Update Posted: Mar 16, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Cook Research Incorporated: Aorta; Thoracic; Aortic dissection; Rupture; Type B; DeBakey type III; Endovascular
• Additional relevant MeSH terms: Aneurysm, Dissecting

Study Results

Participant Flow

Arm/Group Title	Endovascular
Arm/Group Description	Endovascular Treatment (Zenith) Endovascular Treatment (Zenith): Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
Period Title: Overall Study
STARTED	73
5-Year	36
COMPLETED	32
NOT COMPLETED	41

Baseline Characteristics

Arm/Group Title	Endovascular
Arm/Group Description	Endovascular Treatment (Zenith) Endovascular Treatment (Zenith): Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
Overall Participants	73
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.7 (10.9)
Sex: Female, Male (Count of Participants)
Female	25 34.2%
Male	48 65.8%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Freedom From Major Adverse Events
Description	Primary safety : Major adverse events include: myocardial infarction, chronic renal insufficiency/chronic renal failure requiring dialysis, bowel ischemia, stroke, paraplegia or paraparesis, and prolonged ventilator support
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

In accordance with a revised data analysis plan approved under the IDE , 6 patients were excluded from the hypothesis testing due to meeting certain medical exclusion criteria (i.e., patients who were ASA class V or who were without confirmed absence of bowel necrosis at the time of enrollment).Additional information/reference why no analysis was performed for 6 patients is listed in the CIP in section 7.1

Arm/Group Title	Endovascular
Arm/Group Description	Endovascular Treatment (Zenith) Endovascular Treatment (Zenith): Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
Measure Participants	67
Number [participants]	48 65.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Endovascular
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Freedom from Major adverse events (%)
	Estimated Value	71.6
	Confidence Interval	(2-Sided) 95%; 59 to 82
	Parameter Dispersion	Type: Value:
	Estimation Comments	Clopper-Pearson (Exact) Method

2. Primary Outcome

Title	Survival Rate at 30 Days
Description	Primary effectiveness endpoint is freedom from all cause mortality at 30 days
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

In accordance with a revised data analysis plan approved under the IDE , 6 patients were excluded from the hypothesis testing due to meeting certain medical exclusion criteria (i.e., patients who were ASA class V or who were without confirmed absence of bowel necrosis at the time of enrollment). Additional information/reference why no analysis was performed for 6 patients is listed in the CIP in section 7.1

Arm/Group Title	Endovascular
Arm/Group Description	Endovascular Treatment (Zenith) Endovascular Treatment (Zenith): Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
Measure Participants	67
Number [participants]	64 87.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Endovascular
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Survival rate (%)
	Estimated Value	95.5
	Confidence Interval	(2-Sided) 95%; 87 to 99
	Parameter Dispersion	Type: Value:
	Estimation Comments	Clopper-Pearson (Exact) Method

Adverse Events

Time Frame	5-Year
Arm/Group Title	Endovascular
Arm/Group Description	Endovascular Treatment (Zenith) Endovascular Treatment (Zenith): Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
All Cause Mortality
	Endovascular
	Affected / at Risk (%)	# Events
Total	20/73 (27.4%)
Serious Adverse Events
	Endovascular
	Affected / at Risk (%)	# Events
Total	63/73 (86.3%)
Blood and lymphatic system disorders
Anaemia	2/73 (2.7%)	2
Coagulopathy	1/73 (1.4%)	1
Febrile neutropenia	1/73 (1.4%)	1
Thrombocytopenia	2/73 (2.7%)	2
Cardiac disorders
Angina pectoris	4/73 (5.5%)	4
Arrhythmia	4/73 (5.5%)	4
Cardiac Failure Congestive	2/73 (2.7%)	2
Cardiac tamponade	1/73 (1.4%)	1
Coronary artery stenosis	1/73 (1.4%)	1
Mitral valve prolapse	1/73 (1.4%)	1
Myocardial infarction	3/73 (4.1%)	3
Myocardial ischaemia	3/73 (4.1%)	3
Eye disorders
Cataract	1/73 (1.4%)	1
Gastrointestinal disorders
Abdominal hernia	1/73 (1.4%)	1
Abdominal pain	2/73 (2.7%)	2
Abdominal pain lower	2/73 (2.7%)	2
Colitis	1/73 (1.4%)	1
Diarrhoea	1/73 (1.4%)	1
Dysphagia	2/73 (2.7%)	2
Epigastric discomfort	1/73 (1.4%)	1
Erosive oesophagitis	1/73 (1.4%)	1
Gastoroesophageal reflux disease	1/73 (1.4%)	1
Gastric volvulus	1/73 (1.4%)	1
Gastritis	1/73 (1.4%)	1
Gastrointestinal haemorrhage	2/73 (2.7%)	2
Haematemesis	1/73 (1.4%)	1
Haemorrhoidal haemorrhage	1/73 (1.4%)	1
Hiatus hernia	1/73 (1.4%)	1
Ileus paralytic	1/73 (1.4%)	1
Intestinal ischaemia	3/73 (4.1%)	3
Intestinal obstruction	1/73 (1.4%)	1
Large intestine ulcer	1/73 (1.4%)	1
Melaena	1/73 (1.4%)	1
Mouth swelling	1/73 (1.4%)	1
Nausea	1/73 (1.4%)	2
Oesophageal perforation	1/73 (1.4%)	1
Oesophageal stenosis	1/73 (1.4%)	1
Retroperitoneal haemorrhage	1/73 (1.4%)	1
Vomiting	1/73 (1.4%)	2
General disorders
Asthenia	1/73 (1.4%)	1
Chest discomfort	1/73 (1.4%)	1
Chest pain	5/73 (6.8%)	5
Mucosal inflammation	1/73 (1.4%)	1
Multiple organ dysfunction syndrome	3/73 (4.1%)	3
Nodule	1/73 (1.4%)	1
Non-cardiac chest pain	2/73 (2.7%)	2
Pyrexia	2/73 (2.7%)	2
Stent-graft endoleak	3/73 (4.1%)	4
Swelling	1/73 (1.4%)	1
Infections and infestations
Appendicitis	1/73 (1.4%)	1
Bacillus infection	1/73 (1.4%)	1
Bronchitis	1/73 (1.4%)	1
Cellulitis	1/73 (1.4%)	1
Gastroenteritis	1/73 (1.4%)	1
Gastrointestinal infection	1/73 (1.4%)	1
Helicobacter infection	1/73 (1.4%)	1
Influenza	1/73 (1.4%)	1
Pneumonia	4/73 (5.5%)	5
Sepsis	2/73 (2.7%)	3
Urinary tract infection	3/73 (4.1%)	3
Vascular access site infection	2/73 (2.7%)	2
Vascular device infection	1/73 (1.4%)	1
Injury, poisoning and procedural complications
Device use error	1/73 (1.4%)	1
Fall	2/73 (2.7%)	2
Incisional hernia	1/73 (1.4%)	1
Lower limb fracture	1/73 (1.4%)	1
Postoperative respiratory failure	1/73 (1.4%)	1
Seroma	1/73 (1.4%)	2
Skull fracture	1/73 (1.4%)	1
Spinal compression fracture	1/73 (1.4%)	1
Spinal fracture	1/73 (1.4%)	1
Subdural haematoma	1/73 (1.4%)	1
Vascular access site haematoma	1/73 (1.4%)	1
Vascular access site pseudoaneurysm	1/73 (1.4%)	1
Vascular pseudoaneurysm	2/73 (2.7%)	3
Investigations
Blood creatinine increased	2/73 (2.7%)	2
White blood cell count increased	1/73 (1.4%)	1
Metabolism and nutrition disorders
Adult failure to thrive	1/73 (1.4%)	1
Diabetes mellitus	2/73 (2.7%)	2
Hyperglycemia	1/73 (1.4%)	1
Hypovolaemia	1/73 (1.4%)	1
Musculoskeletal and connective tissue disorders
Arthraglia	2/73 (2.7%)	2
Back pain	6/73 (8.2%)	6
Flank pain	1/73 (1.4%)	1
Intervertebral disc degeneration	1/73 (1.4%)	1
Lumbar spinal stenosis	1/73 (1.4%)	1
Muscle spasms	1/73 (1.4%)	1
Muscle weakness	1/73 (1.4%)	1
Pain in extremity	2/73 (2.7%)	2
Rhabdomyolysis	1/73 (1.4%)	1
Spondylolisthesis	1/73 (1.4%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer	1/73 (1.4%)	1
Lung neoplasm malignant	1/73 (1.4%)	1
Myelodysplastic syndrome	1/73 (1.4%)	1
Pancreatic carcinoma metastatic	1/73 (1.4%)	1
Sarcoma metastatic	1/73 (1.4%)	1
Nervous system disorders
Cerebrovascular accident	6/73 (8.2%)	6
Dizziness	1/73 (1.4%)	1
Headache	1/73 (1.4%)	2
Lethargy	1/73 (1.4%)	1
Motor dysfunction	1/73 (1.4%)	1
Nervous system disorder	1/73 (1.4%)	1
Paraparesis	2/73 (2.7%)	2
Paraplegia	2/73 (2.7%)	2
Seizure	1/73 (1.4%)	1
Subarachnoid haemorrhage	1/73 (1.4%)	1
Syncope	1/73 (1.4%)	1
Transient ischaemic attack	3/73 (4.1%)	4
Product Issues
Device lead damage	1/73 (1.4%)	1
Stent malfunction	1/73 (1.4%)	1
Psychiatric disorders
Confusional state	1/73 (1.4%)	1
Delirium	1/73 (1.4%)	1
Mental status changes	2/73 (2.7%)	2
Renal and urinary disorders
Acute kidney injury	2/73 (2.7%)	2
Haematuria	2/73 (2.7%)	3
Renal failure	7/73 (9.6%)	8
Renal tubular necrosis	1/73 (1.4%)	1
Reproductive system and breast disorders
Benign prostatic hyperplasia	1/73 (1.4%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	4/73 (5.5%)	4
Aspiration	1/73 (1.4%)	1
Atelectasis	1/73 (1.4%)	1
Chronic obstructive pulmonary disease	2/73 (2.7%)	2
Diaphragmatic paralysis	1/73 (1.4%)	1
Dyspnoea	1/73 (1.4%)	1
Haemothorax	1/73 (1.4%)	1
Hypoxia	1/73 (1.4%)	1
Orthopnoea	1/73 (1.4%)	1
Pleural effusion	5/73 (6.8%)	5
Pulmonary mass	1/73 (1.4%)	1
Pulmonary oedema	1/73 (1.4%)	1
Respiratory distress	1/73 (1.4%)	1
Respiratory failure	6/73 (8.2%)	6
Surgical and medical procedures
Enterostomy	1/73 (1.4%)	1
Intervertebral disc operation	1/73 (1.4%)	1
Mechanical ventilation	1/73 (1.4%)	1
Vascular disorders
Aortic aneurysm	6/73 (8.2%)	6
Aortic dissection	6/73 (8.2%)	8
Aortic rupture	2/73 (2.7%)	2
Arterial thrombosis	2/73 (2.7%)	2
Haematoma	1/73 (1.4%)	1
Hypertension	3/73 (4.1%)	3
Hypertensive urgency	2/73 (2.7%)	2
Hypotension	1/73 (1.4%)	1
Iliac artery dissection	1/73 (1.4%)	1
Iliac artery occlusion	2/73 (2.7%)	2
Iliac artery stenosis	1/73 (1.4%)	1
Intermittent claudication	2/73 (2.7%)	2
Malignant hypertension	2/73 (2.7%)	2
Peripheral ischaemia	2/73 (2.7%)	2
Subclavian steal syndrome	1/73 (1.4%)	1
Thrombus	1/73 (1.4%)	1
Vascular dissection	1/73 (1.4%)	1
Other (Not Including Serious) Adverse Events
	Endovascular
	Affected / at Risk (%)	# Events
Total	40/73 (54.8%)
Blood and lymphatic system disorders
Anaemia	9/73 (12.3%)	10
Leukocytosis	5/73 (6.8%)	5
Cardiac disorders
Arrhythmia	8/73 (11%)	11
General disorders
Chest pain	6/73 (8.2%)	8
Infections and infestations
Urinary tract infection	11/73 (15.1%)	14
Injury, poisoning and procedural complications
Vascular access site haematoma	5/73 (6.8%)	5
Musculoskeletal and connective tissue disorders
Back pain	8/73 (11%)	9
Nervous system disorders
Headache	4/73 (5.5%)	5
Renal and urinary disorders
Urinary retention	7/73 (9.6%)	7
Respiratory, thoracic and mediastinal disorders
Atelectasis	4/73 (5.5%)	4
Pleural effusion	10/73 (13.7%)	10
Vascular disorders
Hypertension	8/73 (11%)	8

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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.