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

• Sponsor: University of Pisa (Other)
• Overall Status: Completed
• CT.gov ID: NCT01472718
• Collaborator: (none)
• Enrollment: 208
• Arms: 2
• Duration (Months): 36.9

Study Details

Study Description

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.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 208 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of Thromboaspiration in Patients With High Thrombotic Burden Undergoing Primary Percutaneous Coronary Intervention
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Rate of Complete ST-segment Elevation Resolution at 60 Minutes After the End of the Procedure [60 minutes after the end of the procedure]

2. Infarct Size as Assessed by Delayed-enhancement Cardiac Magnetic Resonance Imaging (DE-MRI) [3 months after the index procedure]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• University of Pisa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• Other Study ID Numbers: UP-DCT-201001
• First Posted: Nov 16, 2011
• Last Update Posted: Feb 12, 2019
• Last Verified: Jan 1, 2019

Study Results

Participant Flow

Arm/Group Title	Standard Primary Coronary Intervention	Coronary Thrombectomy
Arm/Group Description	standard primary PCI (with stenting, as required): standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices	coronary thrombectomy: coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)
Period Title: Overall Study
STARTED	104	104
COMPLETED	98	97
NOT COMPLETED	6	7

Baseline Characteristics

Arm/Group Title	Standard Primary Coronary Intervention	Coronary Thrombectomy	Total
Arm/Group Description	standard primary PCI (with stenting, as required): standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices	coronary thrombectomy: coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)	Total of all reporting groups
Overall Participants	104	104	208
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	60 57.7%	58 55.8%	118 56.7%
>=65 years	44 42.3%	46 44.2%	90 43.3%
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	62	63	62
Sex: Female, Male (Count of Participants)
Female	25 24%	16 15.4%	41 19.7%
Male	79 76%	88 84.6%	167 80.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
Italy	104 100%	104 100%	208 100%
coronary TIMI frame count (frames) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [frames]	86 (28)	95 (17)	91 (25)

Outcome Measures

1. Primary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Primary Coronary Intervention	Coronary Thrombectomy
Arm/Group Description	standard primary PCI (with stenting, as required): standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices	coronary thrombectomy: coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)
Measure Participants	104	104
Count of Participants [Participants]	38 36.5%	58 55.8%

2. Primary Outcome

Title	Infarct Size as Assessed by Delayed-enhancement Cardiac Magnetic Resonance Imaging (DE-MRI)
Time Frame	3 months after the index procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Primary Coronary Intervention	Coronary Thrombectomy
Arm/Group Description	standard primary PCI (with stenting, as required): standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices	coronary thrombectomy: coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)
Measure Participants	75	79
Mean (Standard Deviation) [% of LV mass]	19.3 (10.6)	20.4 (10.5)

Adverse Events

Arm/Group Title	Standard Primary Coronary Intervention		Coronary Thrombectomy
Arm/Group Description	standard primary PCI (with stenting, as required): standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices		coronary thrombectomy: coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)
All Cause Mortality
	Standard Primary Coronary Intervention		Coronary Thrombectomy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/104 (1.9%)		2/104 (1.9%)
Serious Adverse Events
	Standard Primary Coronary Intervention		Coronary Thrombectomy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/104 (0%)		0/104 (0%)
Other (Not Including Serious) Adverse Events
	Standard Primary Coronary Intervention		Coronary Thrombectomy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/104 (0%)		0/104 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.