Trial Outcomes & Findings for Silk Road Medical First in Man Study - Neuroprotection During Carotid Stenting and Angioplasty (NCT NCT01264419)

NCT ID: NCT01264419

Last Updated: 2020-02-17

Results Overview

Safety will be evaluated as a composite of major stroke, myocardial infarction and death during the 30-day post procedural period.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 75 participants
• Primary outcome timeframe: 0 days post-procedure to 30 days post-procedure
• Results posted on: 2020-02-17

Participant Flow

Between March 2009 and June 2012 a total of 99 patients were approached about participating in the study. The majority of these individuals (86) were patients of Augusta Krankenhaus in Dusseldorf, Germany, and 13 were patients of the second site, Lukas Krankenhaus, in Neuss, Germany. Study treatment was attempted in 75 study subjects.

All enrolled participants were assigned to the single arm.

Participant milestones

Measure	Silk Road Embolic Protection System Eligible subjects who are to receive a carotid artery stent, via transcervical access using reverse flow cerebral protection, as treatment for high-grade extracranial carotid artery disease
Overall Study STARTED	75
Overall Study COMPLETED	72
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Silk Road Embolic Protection System Eligible subjects who are to receive a carotid artery stent, via transcervical access using reverse flow cerebral protection, as treatment for high-grade extracranial carotid artery disease
Overall Study Lost to Follow-up	3

Baseline Characteristics

Silk Road Medical First in Man Study - Neuroprotection During Carotid Stenting and Angioplasty

Baseline characteristics by cohort

Measure	Single n=75 Participants Carotid angioplasty and stenting with Silk Road Embolic Protection System: Major Adverse Event (MAE) rate with reverse flow neuroprotection
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	75 Participants n=5 Participants
Age, Continuous	72.61 years n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	75 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0 days post-procedure to 30 days post-procedure

Population: Per protocol, all enrolled subjects who had a study device placed in their vasculature and completed the 30-day post-procedure period were included in the final analysis data set.

Safety will be evaluated as a composite of major stroke, myocardial infarction and death during the 30-day post procedural period.

Outcome measures

Measure	Silk Road Embolic Protection System n=75 Participants Eligible subjects who are to receive a carotid artery stent, via transcervical access using reverse flow cerebral protection, as treatment for high-grade extracranial carotid artery disease
Safety Evaluation as Composite of Occurrences of Major Stroke, Myocardial Infarction and Death Major Stroke	0 Occurences
Safety Evaluation as Composite of Occurrences of Major Stroke, Myocardial Infarction and Death Myocardial infarction	0 Occurences
Safety Evaluation as Composite of Occurrences of Major Stroke, Myocardial Infarction and Death Death	0 Occurences

SECONDARY outcome

Timeframe: peri-operative to 30 days post-procedure

Population: Per protocol, all enrolled subjects who had a study device placed in their vasculature and completed the 30-day post-procedure period were included in the final analysis data set

Acute Device Success is calculated by tabulating the number of subjects in whom reverse flow could be established AND who received at least 1 stent; Procedural Success is the freedom from MAEs at 30 days post-procedure, where MAEs are defined in the protocol as "A composite rate of death, major stroke, and myocardial infarction (Q wave and non-Q wave)"; Tolerance to Reverse flow is measured as the absence of "any temporary occurrence of procedure related neurological symptoms following the establishment of the cerebral reverse flow circuit that resolves within 20 minutes of flow manipulation". The number of subjects included in "Tolerance to Reverse Flow" were those subjects for whom reverse flow could be both established and measured.

Outcome measures

Measure	Silk Road Embolic Protection System n=75 Participants Eligible subjects who are to receive a carotid artery stent, via transcervical access using reverse flow cerebral protection, as treatment for high-grade extracranial carotid artery disease
Number of Participants Demonstrating Acute Device Success, Procedural Success, and Tolerance to Reverse Flow Acute device success	68 Participants
Number of Participants Demonstrating Acute Device Success, Procedural Success, and Tolerance to Reverse Flow Procedural Success	68 Participants
Number of Participants Demonstrating Acute Device Success, Procedural Success, and Tolerance to Reverse Flow Tolerance to reverse flow	68 Participants

Adverse Events

Single

Serious events: 10 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Measure	Single n=75 participants at risk Carotid angioplasty and stenting with Silk Road Embolic Protection System: Major Adverse Event (MAE) rate with reverse flow neuroprotection
Nervous system disorders Cranial Nerve Injury	2.7% 2/75 • Number of events 2
Vascular disorders Intracranial bleed	1.3% 1/75 • Number of events 1
Injury, poisoning and procedural complications Incorrect Stent Placement	1.3% 1/75 • Number of events 1
Gastrointestinal disorders Norovirus infection	1.3% 1/75 • Number of events 1
Infections and infestations Urinary tract infection	1.3% 1/75 • Number of events 1
Vascular disorders gastrointestinal bleed	1.3% 1/75 • Number of events 1
Eye disorders retinopaty associated vision loss	1.3% 1/75 • Number of events 1
Cardiac disorders sinus bradycardia	1.3% 1/75 • Number of events 1
Cardiac disorders Cardiac decompensation with edema	1.3% 1/75 • Number of events 1

Other adverse events

Measure	Single n=75 participants at risk Carotid angioplasty and stenting with Silk Road Embolic Protection System: Major Adverse Event (MAE) rate with reverse flow neuroprotection
Cardiac disorders Atrial Fibrillation	2.7% 2/75 • Number of events 2
Cardiac disorders Dyspenia	1.3% 1/75 • Number of events 1
Cardiac disorders Tachycardia	1.3% 1/75 • Number of events 1
Gastrointestinal disorders Procedural vomiting	1.3% 1/75 • Number of events 1
Gastrointestinal disorders Vomiting	1.3% 1/75 • Number of events 1
General disorders Pain	4.0% 3/75 • Number of events 3
General disorders Pyrexia	5.3% 4/75 • Number of events 4
Injury, poisoning and procedural complications Transient procedure intolerance	8.0% 6/75 • Number of events 6
Injury, poisoning and procedural complications Vascular access complication	5.3% 4/75 • Number of events 4
Investigations Blood potassium decreased	1.3% 1/75 • Number of events 1
Investigations Full blood count abnormal	4.0% 3/75 • Number of events 3
Investigations Hemoglobin decreased	1.3% 1/75 • Number of events 1
Investigations Oxygen Saturation decreased	1.3% 1/75 • Number of events 1
Nervous system disorders Dizziness	1.3% 1/75 • Number of events 1
Nervous system disorders Confusion	1.3% 1/75 • Number of events 1
Nervous system disorders Headache	8.0% 6/75 • Number of events 6
Nervous system disorders Sciatica	1.3% 1/75 • Number of events 1
Nervous system disorders Vertigo	1.3% 1/75 • Number of events 1
Respiratory, thoracic and mediastinal disorders Dysphonia	2.7% 2/75 • Number of events 2
Vascular disorders Hematoma	22.7% 17/75 • Number of events 18
Vascular disorders Hypotension	6.7% 5/75 • Number of events 5
Vascular disorders Hypertension	2.7% 2/75 • Number of events 2
Skin and subcutaneous tissue disorders Contact dermatitis	1.3% 1/75 • Number of events 1
Vascular disorders Hemorrhage	4.0% 3/75 • Number of events 3
Investigations Blood CK or CK-MB increase	4.0% 3/75 • Number of events 3
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.3% 1/75 • Number of events 1
Respiratory, thoracic and mediastinal disorders Painful Cough	1.3% 1/75 • Number of events 1
Skin and subcutaneous tissue disorders Rash	1.3% 1/75 • Number of events 1
Surgical and medical procedures Tumor excision	1.3% 1/75 • Number of events 1
Vascular disorders Angina Pectoris	1.3% 1/75 • Number of events 1
Vascular disorders Cerebral Ischemia	1.3% 1/75 • Number of events 1

Additional Information

Richard Ruedy, Exec VP Clinical Affairs

Silk Road Medical, Inc.

Phone: 408-828-7281

Email: ric@silkroadmed.com

Results disclosure agreements

• Principal investigator is a sponsor employee Standard Non-Disclosure agreement and clinical trial agreement publishing policy in addition.
• Publication restrictions are in place

Restriction type: OTHER