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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Anna Sonia Petronio, University of Pisa
ClinicalTrials.gov Identifier:
NCT01472718
First received: November 13, 2011
Last updated: May 24, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Primary PCI for STEMI
Device: coronary thrombectomy
Device: standard primary PCI (with stenting, as required)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Thromboaspiration in Patients With High Thrombotic Burden Undergoing Primary Percutaneous Coronary Intervention

Further study details as provided by University of Pisa:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • infarct size as assessed by delayed-enhancement cardiac magnetic resonance imaging (DE-MRI) [ Time Frame: 3 months after the index procedure ] [ Designated as safety issue: No ]

Enrollment: 208
Study Start Date: February 2009
Study Completion Date: March 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by University of Pisa

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Anna Sonia Petronio, Head of Cardiac Catheterization Laboratory, University of Pisa, Azienda Ospedaliero-Universitaria Pisana, University of Pisa
ClinicalTrials.gov Identifier: NCT01472718     History of Changes
Other Study ID Numbers: UP-DCT-201001
Study First Received: November 13, 2011
Last Updated: May 24, 2012
Health Authority: Italy: Ethics Committee

ClinicalTrials.gov processed this record on October 23, 2014