NCT02552407

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

September 10, 2015

Last Update Submit

October 23, 2017

Conditions

Keywords

thrombectomyacute coronary syndromespercutaneous coronary interventionSTEMI

Outcome Measures

Primary Outcomes (1)

  • Occurrence of Cardiovascular death

    time to event analysis

    up to 30 days

Secondary Outcomes (1)

  • Occurrence of Cardiovascular death

    up to 180 days

Other Outcomes (1)

  • Occurrence of Stroke

    up to 30 days

Study Arms (2)

Manual Aspiration Thrombectomy with PCI

Subjects from the randomized controlled trials to be included in this meta-analysis will have been randomly allocated to Manual Aspiration Thrombectomy followed by percutaneous coronary intervention (PCI).

Device: Manual Aspiration Thrombectomy

PCI Alone

Subjects from the randomized controlled trials to be included in this meta-analysis will have been randomly allocated to percutaneous coronary intervention (PCI) alone without manual aspiration thrombectomy.

Interventions

Thrombus aspiration

Manual Aspiration Thrombectomy with PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with ST elevation myocardial infarction undergoing emergency percutaneous coronary intervention

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Jolly SS, James S, Dzavik V, Cairns JA, Mahmoud KD, Zijlstra F, Yusuf S, Olivecrona GK, Renlund H, Gao P, Lagerqvist B, Alazzoni A, Kedev S, Stankovic G, Meeks B, Frobert O. Thrombus Aspiration in ST-Segment-Elevation Myocardial Infarction: An Individual Patient Meta-Analysis: Thrombectomy Trialists Collaboration. Circulation. 2017 Jan 10;135(2):143-152. doi: 10.1161/CIRCULATIONAHA.116.025371. Epub 2016 Dec 9.

MeSH Terms

Conditions

Myocardial InfarctionAcute Coronary SyndromeST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Sanjit S Jolly, MD

    Population Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2015

First Posted

September 17, 2015

Study Start

September 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

October 25, 2017

Record last verified: 2017-10