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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02552407
Other study ID # ThrombectomyMetaAnalysis
Secondary ID
Status Completed
Phase N/A
First received September 10, 2015
Last updated October 23, 2017
Start date September 2015
Est. completion date November 2016

Study information

Verified date October 2017
Source Population Health Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

During primary percutaneous coronary intervention, distal embolization of thrombus and impaired microvascular perfusion has been associated with an increased mortality. Thrombectomy devices during primary percutaneous coronary intervention may prevent distal embolization by reducing thrombus burden and thus improve microvascular perfusion and reduce mortality.


Description:

An individual patient meta-analysis of large randomized controlled trials comparing manual thrombectomy versus percutaneous coronary intervention alone in patients with ST elevation myocardial infarction will provide significantly more power to detect differences in mortality as well as important but rare events such as stroke and to assess benefits in pre-defined subgroups.


Recruitment information / eligibility

Status Completed
Enrollment 18000
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Randomized controlled trials comparing manual thrombectomy vs. percutaneous coronary intervention alone in patients with ST elevation myocardial infarction published between January 1980 and April 2015.

- Large trials randomizing more than 1000 patients.

- Trials must have had at least 30 day follow up.

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Manual Aspiration Thrombectomy
Thrombus aspiration

Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
Population Health Research Institute Region Örebro County, University Medical Center Groningen, University of Groningen, Uppsala University

Outcome

Type Measure Description Time frame Safety issue
Other Occurrence of Stroke time to event analysis up to 30 days
Primary Occurrence of Cardiovascular death time to event analysis up to 30 days
Secondary Occurrence of Cardiovascular death time to event analysis up to 180 days
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