Trial · NCT02536378
POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE
NCT02536378, Completed, Silk Road Medical; results first posted 2020-07-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE. Trials, record NCT02536378. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02536378
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE
- NCT number
- NCT02536378
- Status
- Completed
- Enrollment
- 692 participants, actual
- Lead sponsor
- Silk Road Medical
- Conditions
- Carotid Artery Disease
- First posted
- 2015-08-31
- Last updated
- 2020-07-29
- Results first posted
- 2020-07-29
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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 |
| Secondary | Number of Participants With Technical Success | 2 hours (periprocedural) | Technical success is defined as acute device success plus the ability to deliver interventional tools |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Procedural Success | 30 Days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Experiencing Major Adverse Event | 30 days | 30 day Major Adverse Events as adjudicated by CEC | Major Adverse Events | NUMBER |
| SECONDARY | Number of Participants With Acute Device Success | 2 hours (periprocedural) | 2 enrolled patients were withdrawn by the Investigator | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Technical Success | 2 hours (periprocedural) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants in Which a Cranial Nerve Injury Occurred | 90 days (extended follow-up) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Procedural Success | PP (Per Protocol) | 630 | Participants | ||
| Number of Participants With Procedural Success | ITT (Intention to Treat) | 690 | Participants | ||
| Number of Participants Experiencing Major Adverse Event | PP (Per Protocol) | Death | 1 | Major Adverse Events | |
| Number of Participants Experiencing Major Adverse Event | ITT (Intention to Treat) | Death | 3 | Major Adverse Events | |
| Number of Participants Experiencing Major Adverse Event | PP (Per Protocol) | Stroke | 4 | Major Adverse Events | |
| Number of Participants Experiencing Major Adverse Event | ITT (Intention to Treat) | Stroke | 13 | Major Adverse Events | |
| Number of Participants Experiencing Major Adverse Event | PP (Per Protocol) | Myocardial Infarction | 6 | Major Adverse Events | |
| Number of Participants Experiencing Major Adverse Event | ITT (Intention to Treat) | Myocardial Infarction | 6 | Major Adverse Events | |
| Number of Participants With Acute Device Success | PP (Per Protocol) | 630 | Participants | ||
| Number of Participants With Acute Device Success | ITT (Intention to Treat) | 690 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PP (Per Protocol) | 632 | |
| Overall Study | STARTED | ITT (Intention to Treat) | 60 | |
| Overall Study | COMPLETED | PP (Per Protocol) | 625 | |
| Overall Study | COMPLETED | ITT (Intention to Treat) | 53 | |
| Overall Study | NOT COMPLETED | PP (Per Protocol) | 7 | |
| Overall Study | NOT COMPLETED | ITT (Intention to Treat) | 7 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Cranial Nerve Injury | Musculoskeletal and connective tissue disorders | PP (Per Protocol) | 8 | 632 | 8 |
| serious | Cranial Nerve Injury | Musculoskeletal and connective tissue disorders | ITT (Intention to Treat) | 10 | 692 | 10 |
| serious | Death - Neurological | Nervous system disorders | PP (Per Protocol) | 0 | 632 | 0 |
| serious | Death - Neurological | Nervous system disorders | ITT (Intention to Treat) | 2 | 692 | 2 |
| serious | Death - Other | General disorders | PP (Per Protocol) | 1 | 632 | 1 |
| serious | Death - Other | General disorders | ITT (Intention to Treat) | 1 | 692 | 1 |
| serious | Myocardial Infarction | Cardiac disorders | PP (Per Protocol) | 6 | 632 | 6 |
| serious | Myocardial Infarction | Cardiac disorders | ITT (Intention to Treat) | 7 | 692 | 7 |
| serious | NPS Device Related Event | Surgical and medical procedures | PP (Per Protocol) | 2 | 632 | 2 |
| serious | NPS Device Related Event | Surgical and medical procedures | ITT (Intention to Treat) | 2 | 692 | 2 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PP (Per Protocol) | 1 | 632 |
| Total, all-cause mortality | ITT (Intention to Treat) | 3 | 692 |
| Total, other adverse events | PP (Per Protocol) | 0 | 0 |
| Total, other adverse events | ITT (Intention to Treat) | 0 | 0 |
| Total, serious adverse events | PP (Per Protocol) | 27 | 632 |
| Total, serious adverse events | ITT (Intention to Treat) | 14 | 692 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| PP (Per Protocol) vs ITT (Intention to Treat): Number of Participants With Technical Success | Trial comparisons |
| PP (Per Protocol) vs ITT (Intention to Treat): Number of Participants With Procedural Success | Trial comparisons |
| PP (Per Protocol) vs ITT (Intention to Treat): Number of Participants With Acute Device Success | Trial comparisons |
| PP (Per Protocol) vs ITT (Intention to Treat): deaths from any cause | Trial comparisons |
| PP (Per Protocol) vs ITT (Intention to Treat): Number of Participants in Which a Cranial Nerve Injury Occurred | Trial comparisons |
| PP (Per Protocol) vs ITT (Intention to Treat): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02536378
GET https://conductscience.org/api/trials/v1/NCT02536378/registered