Trial · NCT00106938

Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease (ACT I)

NCT00106938, Not applicable, Terminated, Abbott Medical Devices; results first posted 2014-10-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease (ACT I). Trials, record NCT00106938. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00106938

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease (ACT I)
NCT number: NCT00106938
Status: Terminated
Phases: Not applicable
Enrollment: 1,663 participants, actual
Lead sponsor: Abbott Medical Devices
Conditions: Carotid Artery Disease, Carotid Stenosis, Stroke, Atherosclerosis
Interventions: Carotid artery stenting with filter (interventional), Carotid artery endarterectomy (surgical)
First posted: 2005-04-04
Last updated: 2017-07-19
Results first posted: 2014-10-21

Source ClinicalTrials.gov

Registered outcomes33

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

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.

1 to 10 of 33Source ClinicalTrials.gov

See all 33 registered outcomes

Outcomes33

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
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		percentage of participants	NUMBER
SECONDARY	Acute Device Success: Xact Carotid Stent	On day 0 after index procedure	Device success is per device basis including the attempted devices only, including the attempted Carotid Artery Stenting (CAS) device only.	percentage of devices	NUMBER
SECONDARY	Acute Device Success: Embolic Protection Device System	On day 0 after index procedure	Device success is per device basis including the attempted devices only, including the attempted Carotid Artery Stenting (CAS) device only.	Percentage of devices	MEAN
SECONDARY	Procedural Success	0 to 30 days post procedure	The analysis population is Procedure success is per subject basis including the attempted CAS (carotid artery stenting) procedure only. CEA group is not part of analysis population for procedure success.	percentage of participants	NUMBER
SECONDARY	Composite Morbidity Measure	0 to 30 Days Post-procedure	Intent-to-Treat (ITT) population	participants	NUMBER
SECONDARY	Freedom From Clinically Indicated Target Lesion Revascularization(CI-TLR)	0 to 180 days		percentage of partcipants	NUMBER
SECONDARY	Freedom From Clinically Indicated Target Lesion Revascularization	0 to 365 days		percentage of partcipants	NUMBER
SECONDARY	Freedom From Clinically Indicated Target Lesion Revascularization	0 to 730 days		percentage of partcipants	NUMBER
SECONDARY	Freedom From Clinically Indicated Target Lesion Revascularization	0 to 1095 days		percentage of partcipants	NUMBER
SECONDARY	Freedom From Clinically Indicated Target Lesion Revascularization	0 to 1460 days		percentage of partcipants	NUMBER

1 to 10 of 33Source ClinicalTrials.gov

See all 33 outcomes

Results by group75

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
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.	CAS Group		3.8		percentage of participants
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.	CEA Group		3.4		percentage of participants
Acute Device Success: Xact Carotid Stent	CAS Group		96.9	95% Confidence Interval 95.6 to 97.8	percentage of devices
Acute Device Success: Embolic Protection Device System	CAS Group		97.8	95% Confidence Interval 96.7 to 98.6	Percentage of devices
Procedural Success	CAS Group		95.6		percentage of participants
Composite Morbidity Measure	CAS Group	Composite morbidity measure	31		participants
Composite Morbidity Measure	CEA Group	Composite morbidity measure	17		participants
Composite Morbidity Measure	CAS Group	Cranial nerve injury	1		participants
Composite Morbidity Measure	CEA Group	Cranial nerve injury	4		participants
Composite Morbidity Measure	CAS Group	Peripheral nerve injury	0.0		participants

1 to 10 of 75Source ClinicalTrials.gov

See all 75 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	CAS Group	1,089
Overall Study	STARTED	CEA Group	364
Overall Study	COMPLETED	CAS Group	913
Overall Study	COMPLETED	CEA Group	293
Overall Study	NOT COMPLETED	CAS Group	176
Overall Study	NOT COMPLETED	CEA Group	71

Source ClinicalTrials.gov

Adverse events170

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	Anesthesia/Procedural medication related	Injury, poisoning and procedural complications	CAS Group	65	1,089	70
other	Anesthesia/Procedural medication related	Injury, poisoning and procedural complications	CEA Group	51	364	55
other	Arrhythmia	Injury, poisoning and procedural complications	CAS Group	140	1,089	148
other	Arrhythmia	Injury, poisoning and procedural complications	CEA Group	20	364	20
other	Cranial nerve injury	Injury, poisoning and procedural complications	CAS Group	14	1,089	15
other	Cranial nerve injury	Injury, poisoning and procedural complications	CEA Group	48	364	51
other	Headache	Injury, poisoning and procedural complications	CAS Group	73	1,089	74
other	Headache	Injury, poisoning and procedural complications	CEA Group	30	364	31
other	Hypertension	Injury, poisoning and procedural complications	CAS Group	40	1,089	40
other	Hypertension	Injury, poisoning and procedural complications	CEA Group	29	364	29

1 to 10 of 170Source ClinicalTrials.gov

See all 170 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	CAS Group
Total, all-cause mortality	CEA Group
Total, other adverse events	CAS Group	635	1,089
Total, other adverse events	CEA Group	216	364
Total, serious adverse events	CAS Group	376	1,089
Total, serious adverse events	CEA Group	118	364

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26886419	DERIVED	PubMed
28982691	DERIVED	PubMed

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
CAS Group vs CEA 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00106938

GET https://conductscience.org/api/trials/v1/NCT00106938/registered?page=2

API reference For AI assistants