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NCT00402740: PROTECT
Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA)
NA trial testing Xact Stent with either Emboshield Pro (Gen 5) or Emboshield (Gen 3) in Carotid Artery Disease in 322 participants. Completed in 1 October 2011.
1 June 2011
Quick facts
| Lead sponsor | Abbott Medical Devices |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 322 |
| Start date | 1 November 2006 |
| Primary completion | 1 June 2011 |
| Estimated completion | 1 October 2011 |
| Sites | 38 locations across United States |
Drugs / interventions tested
- Xact Stent with either Emboshield Pro (Gen 5) or Emboshield (Gen 3)
Conditions studied
- Carotid Artery Disease — all drugs for Carotid Artery Disease →
Sponsor
Abbott Medical Devices — full company profile →
Who can join
18 and older, any sex, with Carotid Artery Disease. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Kaplan-Meier Estimate of Freedom From the Composite of Any Death, Stroke and MI During the 30 Day Post Procedural Period (DSMI), Plus Fatal and Non-fatal Ipsilateral Stroke From 31-365 Days and Annually Thereafter for a Total of 3 Years.
Time frame: 3 years
Freedom from DSMI to 30 days or ipsilateral stroke from 31 days to 3 years. KM event free (%) curve.
Sponsor's own description
The purpose of this study is to evaluate the long-term safety and efficacy of the Xact™ Rapid Exchange Carotid Stent System used in conjunction with the Emboshield® Pro Rapid Exchange Embolic Protection System (Generation 5) and the Emboshield® BareWire™ Rapid Exchange Embolic Protection System (Generation 3), in the treatment of atherosclerotic carotid artery disease in high-surgical risk subjects.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00402740
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Carotid Artery Disease
Currently open trials in the same condition.
- NCT07200180 — Perioperative Argon Inhalation to Improve Neurocognitive Recovery After Carotid Surgery · Phase 3 · recruiting
- NCT02850588 — SVS VQI TransCarotid Revascularization Surveillance Project · recruiting
- NCT01597453 — NOR-SYS: The Norwegian Stroke in the Young Study · NA · active not recruiting
Other Abbott Medical Devices trials
Trials by the same sponsor.
- NCT07421076 — Grid eXplore Mapping Study · NA · recruiting
- NCT07509658 — TriClip Japan Post-Approval Study · recruiting
- NCT07361445 — Agilis RF TSP Early Feasibility Study · NA · recruiting
- NCT07373353 — A Clinical Evaluation of AMJ-401 · NA · recruiting
- NCT07217392 — Left Bundle Branch Area Pacing (LBBAP) PMCF Study · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00402740 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Abbott Medical Devices
- Last refreshed: 17 May 2012
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00402740.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing