Thromboaspiration in Patients With High Thrombotic Burden Undergoing Primary Percutaneous Coronary Intervention (PCI)

January 21, 2019 updated by: Prof. Anna Sonia Petronio, University of Pisa

Efficacy of Thromboaspiration in Patients With High Thrombotic Burden Undergoing Primary Percutaneous Coronary Intervention

200 consecutive patients presenting with STEMI within 12 hours from the onset of symptoms and having a high thrombotic burden at coronary angiography, defined as the presence of a thrombus size ≥ 2 times the diameter of the vessel, according to a visual estimate. The main objective of the study is to evaluate the effectiveness of thrombectomy (either rheolytic or manual aspiration) as an adjunct to primary or rescue angioplasty, in patients with angiographic evidence high thrombotic burden in the culprit artery. Primary end points: (1) rate of complete ST-segment elevation resolution at 60 minutes after the end of the procedure; (2) infarct size as assessed by delayed-enhancement cardiac magnetic resonance imaging (DE-MRI) at 3 months after the index procedure.

Secondary endpoints: post-procedural TIMI flow grade; post-procedural MBG; infarct transmurality at 3 months; MVO at 3 months; 1-year actuarial freedom from MACEs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Prolonged, continuous signs and symptoms of ischemia lasting more than 20 min, starting within 12 hours prior to randomization, and ST elevation ≥ 2mm in ≥2 contiguous ECG leads, or new left bundle branch block (LBBB)
  2. Presence of high thrombotic burden in the culprit lesion at diagnostic angiography (defined as the presence of a thrombus size ≥ 2 times the diameter of the vessel, according to a visual estimate, or abrupt cut-off occlusion of a coronary artery ≥3 mm in reference vessel diameter)
  3. Written informed consent

Exclusion Criteria:

  • Low-risk (ST elevation in ≤2 leads) inferior AMI
  • Previous infarction in the same area (assessed by ECG)
  • PCI in the 2 weeks prior to AMI
  • Active internal bleeding
  • History of cerebrovascular accident in the previous 2 years or cerebrovascular accident with a significant residual neurological deficit
  • Head or spine surgery or trauma in the previous 2 months
  • Recent (within six weeks) gastrointestinal (GI) or genitourinary (GU) bleeding of clinical significance
  • Administration of oral anticoagulants within seven days unless prothrombin time is <1.2 times control
  • Bleeding diathesis or severe uncontrolled arterial hypertension
  • Thrombocytopenia (<100 000 cells/mL)
  • Recent (within six weeks) major surgery or trauma
  • Intracranial neoplasm, arteriovenous malformation, or aneurysm
  • Severe renal or liver failure
  • Allergy to aspirin
  • Contraindication to MRI examination
  • Pregnancy and lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard primary coronary intervention
Device: standard primary PCI (with stenting, as required)
standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices
Experimental: coronary thrombectomy
Device: coronary thrombectomy
coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of Complete ST-segment Elevation Resolution at 60 Minutes After the End of the Procedure
Time Frame: 60 minutes after the end of the procedure
60 minutes after the end of the procedure
Infarct Size as Assessed by Delayed-enhancement Cardiac Magnetic Resonance Imaging (DE-MRI)
Time Frame: 3 months after the index procedure
3 months after the index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pisa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

November 13, 2011

First Submitted That Met QC Criteria

November 15, 2011

First Posted (Estimate)

November 16, 2011

Study Record Updates

Last Update Posted (Actual)

February 12, 2019

Last Update Submitted That Met QC Criteria

January 21, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • UP-DCT-201001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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