Trial Outcomes & Findings for Thromboaspiration in Patients With High Thrombotic Burden Undergoing Primary Percutaneous Coronary Intervention (PCI) (NCT NCT01472718)

NCT ID: NCT01472718

Last Updated: 2019-02-12

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 208 participants
• Primary outcome timeframe: 60 minutes after the end of the procedure
• Results posted on: 2019-02-12

Participant Flow

Participant milestones

Measure	Standard Primary Coronary Intervention 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: coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)
Overall Study STARTED	104	104
Overall Study COMPLETED	98	97
Overall Study NOT COMPLETED	6	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Standard Primary Coronary Intervention n=104 Participants 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 n=104 Participants coronary thrombectomy: coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)	Total n=208 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=104 Participants	0 Participants n=104 Participants	0 Participants n=208 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=104 Participants	58 Participants n=104 Participants	118 Participants n=208 Participants
Age, Categorical >=65 years	44 Participants n=104 Participants	46 Participants n=104 Participants	90 Participants n=208 Participants
Age, Continuous	62 years n=104 Participants	63 years n=104 Participants	62 years n=208 Participants
Sex: Female, Male Female	25 Participants n=104 Participants	16 Participants n=104 Participants	41 Participants n=208 Participants
Sex: Female, Male Male	79 Participants n=104 Participants	88 Participants n=104 Participants	167 Participants n=208 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Italy	104 participants n=104 Participants	104 participants n=104 Participants	208 participants n=208 Participants
coronary TIMI frame count	86 frames STANDARD_DEVIATION 28 • n=104 Participants	95 frames STANDARD_DEVIATION 17 • n=104 Participants	91 frames STANDARD_DEVIATION 25 • n=208 Participants

PRIMARY outcome

Timeframe: 60 minutes after the end of the procedure

Outcome measures

Measure	Standard Primary Coronary Intervention n=104 Participants 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 n=104 Participants coronary thrombectomy: coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)
Rate of Complete ST-segment Elevation Resolution at 60 Minutes After the End of the Procedure	38 Participants	58 Participants

PRIMARY outcome

Timeframe: 3 months after the index procedure

Outcome measures

Measure	Standard Primary Coronary Intervention n=75 Participants 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 n=79 Participants coronary thrombectomy: coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)
Infarct Size as Assessed by Delayed-enhancement Cardiac Magnetic Resonance Imaging (DE-MRI)	19.3 % of LV mass Standard Deviation 10.6	20.4 % of LV mass Standard Deviation 10.5

Adverse Events

Standard Primary Coronary Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Coronary Thrombectomy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marco De Carlo, MD, PHD

Cardiac Catheterization Laboratory, Cardiothoracic and Vascular Department, Azienda Ospedaliero-Universitaria Pisana,

Phone: +39 050995326

Email: marcodecarlo@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place