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

NCT01472718 | Completed Phase 4 Results

• 1 other identifier: UP-DCT-201001
• Study Type: interventional
• Target: 208
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Primary PCI for STEMI

Outcome Measures

Primary Outcomes (2)

• Rate of Complete ST-segment Elevation Resolution at 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)

  3 months after the index procedure

Study Arms (2)

standard primary coronary intervention

ACTIVE COMPARATOR

Device: standard primary PCI (with stenting, as required)

coronary thrombectomy

EXPERIMENTAL

Device: coronary thrombectomy

Interventions

coronary thrombectomy DEVICE

coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)

coronary thrombectomy

standard primary PCI (with stenting, as required) DEVICE

standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices

standard primary coronary intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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)
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pisa: lead

Related Publications (1)

• De Carlo M, Aquaro GD, Palmieri C, Guerra E, Misuraca L, Giannini C, Lombardi M, Berti S, Petronio AS. A prospective randomized trial of thrombectomy versus no thrombectomy in patients with ST-segment elevation myocardial infarction and thrombus-rich lesions: MUSTELA (MUltidevice Thrombectomy in Acute ST-Segment ELevation Acute Myocardial Infarction) trial. JACC Cardiovasc Interv. 2012 Dec;5(12):1223-30. doi: 10.1016/j.jcin.2012.08.013.

  PMID: 23257370 DERIVED

Results Point of Contact

• Title: Marco De Carlo, MD, PHD
• Organization: Cardiac Catheterization Laboratory, Cardiothoracic and Vascular Department, Azienda Ospedaliero-Universitaria Pisana,

marcodecarlo@gmail.com

+39 050995326

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiac Catheterization Laboratory, University of Pisa, Azienda Ospedaliero-Universitaria Pisana

Study Record Dates

• First Submitted: November 13, 2011
• First Posted: November 16, 2011
• Study Start: February 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: March 1, 2012
• Last Updated: February 12, 2019
• Results First Posted: February 12, 2019

Record last verified: 2019-01