Trial · NCT00816166
VISSIT Intracranial Stent Study for Ischemic Therapy
NCT00816166, Phase 2, Phase 3, Terminated, Codman & Shurtleff; results first posted 2014-06-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. VISSIT Intracranial Stent Study for Ischemic Therapy. Trials, record NCT00816166. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00816166
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- VISSIT Intracranial Stent Study for Ischemic Therapy
- NCT number
- NCT00816166
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 125 participants, actual
- Lead sponsor
- Codman & Shurtleff
- Conditions
- Ischemic Stroke, Transient Ischemic Attack
- Interventions
- Pharos Vitesse Neurovascular Stent System (Stent implantation) + Medical therapy (Aspirin and Clopidogrel), Aspirin and Clopidogrel (Medical therapy)
- First posted
- 2008-12-31
- Last updated
- 2015-02-20
- Results first posted
- 2014-06-16
- Limitations and caveats
Early termination of enrollment led to small numbers of subjects analyzed (less than 50% of the prospectively planned sample size). Various endpoints, subgroup and sensitivity analyses were not conducted because the study was not fully enrolled.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Successful Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months | One Year | The primary effectiveness endpoint was a composite of the two following outcomes: * Stroke in the same territory (distal to the target lesion) as the presenting event within 12 months of randomization * Hard Transient Ischemic Attack (TIA) in the same territory (distal to the target lesion) as the presenting event from day 2 through month 12 post-randomization A subject was deemed to be a primary endpoint success if neither of these outcomes occurred. The Kaplan-Meier success rate at 12-months post-operatively was calculated with Kaplan-Meier time-to-event methodology, where the time variable for patients who were successful (no stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of last follow-up, and the time variable for patients who were not successful (had a stroke within 12 months or hard TIA between 2 days and 12 months) was censored at the time of the first event (stroke with 12 months or hard TIA between 2 days and 12 months). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Successful Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months | One Year | Analyses were based on an intent-to-treat (ITT) population, defined as enrolled subjects who met the inclusion/exclusion criteria and who were randomized post angiogram. Stent and Medical Therapy Group subjects were analyzed according to their ITT randomized group regardless of treatment received. | percent probability | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Successful Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months | Stent Group | 62.24 | 95% Confidence Interval 48.15 to 73.15 | percent probability | |
| Successful Outcome: No Stroke or Hard TIA in the Same Territory Within 12 Months | Medical Therapy Group | 83.68 | 95% Confidence Interval 69.94 to 91.50 | percent probability |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stent Group | 59 | |
| Overall Study | STARTED | Medical Therapy Group | 53 | |
| Overall Study | ITT Population (Met Eligibility) | Stent Group | 58 | |
| Overall Study | ITT Population (Met Eligibility) | Medical Therapy Group | 53 | |
| Overall Study | COMPLETED | Stent Group | 49 | |
| Overall Study | COMPLETED | Medical Therapy Group | 41 | |
| Overall Study | NOT COMPLETED | Stent Group | 10 | |
| Overall Study | NOT COMPLETED | Medical Therapy Group | 12 |
Source ClinicalTrials.gov
Adverse events448
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 |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Stent Group | 3 | 58 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Medical Therapy Group | 2 | 53 | 2 |
| other | Coagulopathy | Blood and lymphatic system disorders | Stent Group | 0 | 58 | 0 |
| other | Coagulopathy | Blood and lymphatic system disorders | Medical Therapy Group | 1 | 53 | 1 |
| other | Haemoglobin decreased | Blood and lymphatic system disorders | Stent Group | 1 | 58 | 1 |
| other | Haemoglobin decreased | Blood and lymphatic system disorders | Medical Therapy Group | 0 | 53 | 0 |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Stent Group | 0 | 58 | 0 |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Medical Therapy Group | 1 | 53 | 1 |
| other | Bradycardia | Cardiac disorders | Stent Group | 1 | 58 | 1 |
| other | Bradycardia | Cardiac disorders | Medical Therapy Group | 0 | 53 | 0 |
1 to 10 of 448Source ClinicalTrials.gov
See all 448 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stent Group | ||
| Total, all-cause mortality | Medical Therapy Group | ||
| Total, other adverse events | Stent Group | 37 | 58 |
| Total, other adverse events | Medical Therapy Group | 34 | 53 |
| Total, serious adverse events | Stent Group | 30 | 58 |
| Total, serious adverse events | Medical Therapy Group | 20 | 53 |
Source ClinicalTrials.gov
Papers7
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Stent Group vs Medical Therapy Group: serious adverse events |
Source 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/NCT00816166
GET https://conductscience.org/api/trials/v1/NCT00816166/events?page=2