the Effect of Prolonged Inflation Time During Stents Deployment for ST-elevation Myocardial Infarction

Acute ST-elevation Myocardial Infarction Clinical Trial

Official title:

the Effect of Prolonged Inflation Time During Drug-eluting Stents Deployment Compared With Conventional Method for ST-elevation Myocardial Infarction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03199014
• Other study ID #: WestChinaH-CVD-001
• Status: Recruiting
• Phase: N/A
• First received: December 10, 2016
• Last updated: July 4, 2017
• Start date: December 2016
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: West China Hospital
• Contact: He yong
• Phone: +8618980602038
• Email: zznnyeah[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether prolonged inflation time on drug-eluting stents deployment for ST-elevation myocardial Infarction was better than conventional stents deployment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• men and women =18 years with ST-elevation Myocardial Infarction;

• patients with STEMI and ischemic symptoms of less than 12 hours'duration;

• patients with STEMI and ischemic symptoms of less than 12 hours' duration who have contraindications to fibrinolytic therapy, irrespective of the time delay from FMC;

• patients with STEMI if there is clinical and/or ECG evidence of ongoing ischemia between 12 and 24 hours after symptom onset;

• when angiography was completed, guide wire could cross the lesion in the culprit vessel, TIMI=1,with feasibility to direct stenting

Exclusion Criteria:

• cardiac shock, or acute severe heart failure;

• the lesion was highly calcified, excessive proximal tortuosity,left main artery lesion, restenosis lesion,vein graft lesion,total occlusions;

• True bifurcation lesions;

• Stenosis=50% and TIMI flow grade 3;

• history of PCI in target vessel;

• diameter of the target vessel less than 2 mm;

• severe liver and kidney dysfunction;

• inability to give informed written consent.

Related Conditions & MeSH terms

• Acute ST-elevation Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Device:
• deploying the Drug-eluting Stents with a prolonged time
the inflation time was more than 30 seconds when the Drug-eluting Stents deploying.The PROMUS Element Plus Stent or Co-Cr sirolimus-eluting coronary stent system(GuReater)was used in this study
• deploying the Drug-eluting Stents with a conventional time
the actual inflation time was within 10s determined by interventional cardiologist.The PROMUS Element Plus Stent or Co-Cr sirolimus-eluting coronary stent system(GuReater)was used in this study

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

Gibson CM, Cannon CP, Daley WL, Dodge JT Jr, Alexander B Jr, Marble SJ, McCabe CH, Raymond L, Fortin T, Poole WK, Braunwald E. TIMI frame count: a quantitative method of assessing coronary artery flow. Circulation. 1996 Mar 1;93(5):879-88. — View Citation

Gibson CM, Murphy SA, Rizzo MJ, Ryan KA, Marble SJ, McCabe CH, Cannon CP, Van de Werf F, Braunwald E. Relationship between TIMI frame count and clinical outcomes after thrombolytic administration. Thrombolysis In Myocardial Infarction (TIMI) Study Group. Circulation. 1999 Apr 20;99(15):1945-50. — View Citation

Hovasse T, Mylotte D, Garot P, Salvatella N, Morice MC, Chevalier B, Pichard A, Lefèvre T. Duration of balloon inflation for optimal stent deployment: five seconds is not enough. Catheter Cardiovasc Interv. 2013 Feb;81(3):446-53. doi: 10.1002/ccd.23343. Epub 2012 Jan 10. — View Citation

Li C, Zhang B, Li M, Liu J, Wang L, Liu Y, Wang Z, Wen S. Comparing Direct Stenting With Conventional Stenting in Patients With Acute Coronary Syndromes: A Meta-Analysis of 12 Clinical Trials. Angiology. 2016 Apr;67(4):317-25. doi: 10.1177/0003319715585662. Epub 2015 May 11. — View Citation

Ozdemir R, Sezgin AT, Barutcu I, Topal E, Gullu H, Acikgoz N. Comparison of direct stenting versus conventional stent implantation on blood flow in patients with ST-segment elevation myocardial infarction. Angiology. 2006 Aug-Sep;57(4):453-8. — View Citation

Sabatier R, Hamon M, Zhao QM, Burzotta F, Lecluse E, Valette B, Grollier G. Could direct stenting reduce no-reflow in acute coronary syndromes? A randomized pilot study. Am Heart J. 2002 Jun;143(6):1027-32. — View Citation

van 't Hof AW, Liem A, Suryapranata H, Hoorntje JC, de Boer MJ, Zijlstra F. Angiographic assessment of myocardial reperfusion in patients treated with primary angioplasty for acute myocardial infarction: myocardial blush grade. Zwolle Myocardial Infarction Study Group. Circulation. 1998 Jun 16;97(23):2302-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Procedural time	minute	form start puncturing vascular until the operation was completed intraoperative
Other	Radiation exposure time	minute	form start puncturing vascular until the operation was completed intraoperative
Primary	Number of Participants With TIMI 3	TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion.TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed.TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory.TIMI 3 is normal flow which fills the distal coronary bed completely	1 minute after sent was deployed
Primary	corrected TIMI frame count(frames)	Grading was done on cinefilm at 15frames/s made in a Philips digital coronary imaging catheterization laboratory.	1 minute after sent was deployed
Primary	myocardial blush grade	0, no myocardial blush or contrast density; 1, minimal myocardial blush or contrast density; 2,moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsilateral non- infarct-related coronary artery; and 3, normal myocardial blush or contrast density, comparable with that obtained during angiography of a contralateral or ipsilateral non-infarct-related coronary artery	1 minute after sent was deployed
Secondary	Number of Participants ST-segment resolution	1, normalized, defined as no residual ST-segment elevation; 2, improved, defined as a residual ST-segment elevation ,70% of with that on the first ECG; and 3, unchanged, defined as a residual ST-segment elevation 70% of that on the first ECG	60min after the operation
Secondary	Number of Participants Death from cardiac causes	death from acute myocardial infarction, cardiac perforation, or pericardial tamponade; an arrhythmia or conduction abnormality; complications of the interventional procedure at baseline	one month after the operation
Secondary	Number of Participants Target-vessel revascularization	any revascularization intervention (PCI or CABG) occurring in a treated vessel at any time after the index intervention.	one month after the operation
Secondary	Number of Participants stent thrombosis	evidence of any myocardial infarction with angiographic confirmation of in-stent thrombus or unexplained death within 30 days after the procedure as stent thrombosis	one month after the operation
Secondary	Number of Participants had Major bleeding	any symptomatic intracranial hemorrhage, or clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of>= g/dL (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of>=15%)	one month after the operation