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

NCT03199014 | Unknown

• 1 other identifier: WestChinaH-CVD-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute ST-elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Number of Participants ST-segment resolution

  60min after the operation

• Number of Participants Death from cardiac causes

  one month after the operation

• Number of Participants Target-vessel revascularization

  one month after the operation

• Number of Participants stent thrombosis

  one month after the operation

• Number of Participants had Major bleeding

  one month after the operation

Other Outcomes (2)

• Procedural time

  form start puncturing vascular until the operation was completed intraoperative

• Radiation exposure time

  form start puncturing vascular until the operation was completed intraoperative

Study Arms (2)

prolonged deployment strategy group

EXPERIMENTAL

in "deploying the Drug-eluting Stents with a prolonged time" group,the inflation time was more than 30 seconds when the Drug-eluting Stents deploying,unless the patients was unstable.

Device: deploying the Drug-eluting Stents with a prolonged time

rapid deployment strategy group

ACTIVE COMPARATOR

in "deploying the Drug-eluting Stents with a conventional time" group, a conventional method was used to deploying drug-eluting stents,the actual inflation time was within 10s determined by interventional cardiologist.

Device: deploying the Drug-eluting Stents with a conventional time

Interventions

deploying the Drug-eluting Stents with a prolonged time DEVICE

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

prolonged deployment strategy group

deploying the Drug-eluting Stents with a conventional time DEVICE

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

rapid deployment strategy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 621000, China

RECRUITING

Related Publications (8)

• 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. doi: 10.1067/mhj.2002.122509.

  PMID: 12075259 BACKGROUND

• 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. doi: 10.1177/0003319706290620.

  PMID: 17022381 BACKGROUND

• 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.

  PMID: 25964649 BACKGROUND

• Hovasse T, Mylotte D, Garot P, Salvatella N, Morice MC, Chevalier B, Pichard A, Lefevre 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.

  PMID: 22109977 BACKGROUND

• 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. doi: 10.1161/01.cir.97.23.2302.

  PMID: 9639373 BACKGROUND

• 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. doi: 10.1161/01.cir.99.15.1945.

  PMID: 10208996 BACKGROUND

• 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. doi: 10.1161/01.cir.93.5.879.

  PMID: 8598078 BACKGROUND

• Ma M, Wang L, Diao KY, Liang SC, Zhu Y, Wang H, Wang M, Zhang L, Yang ZG, He Y. A randomized controlled clinical trial of prolonged balloon inflation during stent deployment strategy in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: a pilot study. BMC Cardiovasc Disord. 2022 Feb 4;22(1):30. doi: 10.1186/s12872-022-02477-0.

  PMID: 35120436 DERIVED

Study Officials

• He yong

  west china hospital of sichuan univercity

  STUDY DIRECTOR

Central Study Contacts

He yong

CONTACT

+8618980602038; zznnyeah@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2016
• First Posted: June 26, 2017
• Study Start: December 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 6, 2017

Record last verified: 2017-07

Locations

CN (1)