Trial · NCT00106938
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite of Death, Stroke (Ipsilateral or Contralateral; Major or Minor) and Myocardial Infarction (DSMI) Through 30 Days Post-procedure, Plus Ipsilateral Stroke 31 to 365 Days. | 0 to 365 days | |
| Secondary | Acute Device Success: Xact Carotid Stent | On day 0 after index procedure | Defined as attainment of final residual diameter stenosis of \< 50% by Qualitative Comparative Analysis (QCA) (if QCA is not available, the visual estimate of diameter stenosis will be used) covering an area no longer than the original lesion with the study stent. (Routine post-dilatation of the stent may be included in this definition). Placement of an additional stent to treat a dissection or procedural complication as a bailout will not be considered a device success. |
| Secondary | Acute Device Success: Embolic Protection Device System | On day 0 after index procedure | Defined as successful deployment and retrieval of the filter in the absence of angiographic distal embolization. |
| Secondary | Procedural Success | 0 to 30 days post procedure | Procedural success is defined as the attainment of target lesion final residual diameter stenosis of \< 50% by QCA (if QCA is not available, the visual estimate of diameter stenosis will be used) using any procedural method and freedom of Major Adverse Event at 30 days. |
| Secondary | Composite Morbidity Measure | 0 to 30 Days Post-procedure | A pre-specified composite Morbidity Measure (CMM) of cranial and peripheral nerve injury, vascular injury, non-cerebral bleeding, wound complications related to the neck incision or femoral puncture site, and other complications (anesthetic) at 30 days post-procedure. |
| Secondary | Freedom From Clinically Indicated Target Lesion Revascularization(CI-TLR) | 0 to 180 days | Freedom from CI-TLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients. |
| Secondary | Freedom From Clinically Indicated Target Lesion Revascularization | 0 to 365 days | Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients. |
| Secondary | Freedom From Clinically Indicated Target Lesion Revascularization | 0 to 730 days | Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients. |
| Secondary | Freedom From Clinically Indicated Target Lesion Revascularization | 0 to 1095 days | Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients. |
| Secondary | Freedom From Clinically Indicated Target Lesion Revascularization | 0 to 1460 days | Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients. |
| Secondary | Freedom From Clinically Indicated Target Lesion Revascularization | 0 to 1825 days | Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients. |
| Secondary | Freedom From Ipsilateral Stroke | 31 to 365 days | Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes. |
| Secondary | Freedom From Ipsilateral Stroke | 31 to 730 days | Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes. |
| Secondary | Freedom From Ipsilateral Stroke | 31 to 1095 days | Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes. |
| Secondary | Freedom From Ipsilateral Stroke | 31 to 1460 days | Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes. |
| Secondary | Freedom From Ipsilateral Stroke | 31 to 1825 days | Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes. |
| Secondary | Freedom From Mortality | 0 to 365 days | |
| Secondary | Freedom From Mortality | 0 to 730 days | |
| Secondary | Freedom From Mortality | 0 to 1095 days | |
| Secondary | Freedom From Mortality | 0 to 1460 days |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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