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Rapid Inflation/Deflation Compared With Prolonged High-Pressure Balloon Inflation (INFLATION/DE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Central Arkansas Veterans Healthcare System
Sponsor:
Information provided by (Responsible Party):
Central Arkansas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT01952873
First received: September 18, 2013
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

It is universally accepted that high-pressure balloon inflation is required to most effectively deploy a coronary balloon-expandable stent. However, there is not consensus nor are there any guidelines regarding the method of balloon inflation, particularly the duration of inflation. Underexpansion and strut malapposition after stent deployment are among the most powerful predictors for adverse vessel outcomes. High-pressure inflation for stent deployment is effective to optimally expand the stent, but unlike in vitro testing in air, there are poorly distensible plaque elements that may not instantaneously yield to the balloon pressure. However, these elements may ultimately yield to prolonged inflation. Most clinical interventional cardiologists inflate for a relatively short period (15-30 sec). The investigators have noted that when balloon pressure is maintained at a certain pressure level it tends to decrease over time, and may require 60-180 or more seconds to maintain pressure stability. This finding implies that plaque elements are yielding slowly over time to the increased pressure, thus increasing expansion, and suggests that a prolonged inflation until balloon pressure stabilizes is more effective than a rapid inflation/deflation sequence to fully expand and appose the stent to the vessel wall. At present there is no consensus on stent deployment strategy. It is our hypothesis that prolonged inflation is superior to the more commonly used strategy of rapid inflation/deflation.

Optimal coherence tomography (OCT), a novel technology that measures near-infrared light reflections and translates them into a 2D image, has an axial resolution nearly 10-times that of intravascular ultrasound (IVUS). Thus it is possible to examine the extent of stent apposition and stent expansion using this modality.

The current randomized trial tests the hypothesis that prolonged balloon inflation until a stable balloon pressure is maintained is more effective than a rapid inflation/deflation sequence when performed to the same balloon inflation pressure.


Condition Intervention
Coronary Artery Disease
Coronary Stent Occlusion
Other: Prolonged inflation
Other: Rapid inflation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rapid Inflation/Deflation Compared With Prolonged High-Pressure Balloon Inflation on the Results of Stent Deployment

Further study details as provided by Central Arkansas Veterans Healthcare System:

Primary Outcome Measures:
  • Number of unapposed stent struts [ Time Frame: Day 1 Within first hour after after stent deployment ] [ Designated as safety issue: No ]
  • Minimal luminal stent area [ Time Frame: Day 1 Within first hour after after stent deployment ] [ Designated as safety issue: No ]
  • Minimal lumen stent diameter [ Time Frame: Day 1 Within first hour after after stent deployment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of unapposed stent struts/mm of stent [ Time Frame: Day 1 Within first hour after stent deployment ] [ Designated as safety issue: No ]
  • % of patients with complete stent apposition [ Time Frame: Day 1 Within first hour after stent deployment ] [ Designated as safety issue: No ]
  • Symptomatic ischemia requiring balloon deflation [ Time Frame: Intra-procedure ] [ Designated as safety issue: Yes ]
  • Serious arrhythmia [ Time Frame: Intra-procedure and first hour post-PCI ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: December 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rapid
The rapid inflation method will consist of reaching an operator determined high-pressure (16 atm) with the stent-deployment balloon and maintaining it the duration of time determined by the operator but <30 sec if the balloon is fully inflated and longer only if the balloon requires a longer duration to become fully inflated.
Other: Rapid inflation
The rapid inflation method will consist of reaching an operator determined high-pressure (16 atm) with the stent-deployment balloon and maintaining it the duration of time determined by the operator but <30 sec if the balloon is fully inflated and longer only if the balloon requires a longer duration to become fully inflated.
Experimental: Prolonged
Prolonged inflation will be performed at high pressure(16 atm)and maintained for 30 sec with <0.3 atm drop during that period.
Other: Prolonged inflation
Prolonged inflation will be performed at high pressure(16 atm)and maintained for 30 sec with <0.3 atm drop during that period.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients >18 years old with coronary disease with clinical indication for single stent placement in a lesion with a 2.5-3.5 mm diameter and who require OCT for determination of effective stent placement .

Exclusion Criteria:

1. ST segment elevation myocardial infarction 2. Chronic total occlusion 3. Bifurcation lesion or major side branch (>2.5 mm) within the stented area 4. Need for overlapping stents 5. Clinical instability including cardiogenic shock 6. Inability to give informed consent 7. Chronic kidney disease with serum creatinine >1.8 mg/dL 8. Unprotected left main stenosis

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01952873

Contacts
Contact: Kristin Miller, RN 501-257-5893 kristin.miller4@va.gov
Contact: Lauren Landers 501-257-5842 lauren.landers@va.gov

Locations
United States, Arkansas
John L. McClellan Memorial Veterans Hospital Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Aaron Bayles, RN    501-257-5893    aaron.bayles@va.gov   
Contact: Kristin Miller, RN    5012575842    kmiller4@uams.edu   
Principal Investigator: Barry F Uretsky, MD         
Sponsors and Collaborators
Central Arkansas Veterans Healthcare System
Investigators
Principal Investigator: Barry F Uretsky, M.D. Central Arkansas Veterans' Healthcare System
  More Information

Publications:
Responsible Party: Central Arkansas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT01952873     History of Changes
Other Study ID Numbers: 287332
Study First Received: September 18, 2013
Last Updated: July 11, 2014
Health Authority: United States: Federal Government

Keywords provided by Central Arkansas Veterans Healthcare System:
stents
angioplasty, balloon, coronary
coronary artery stenosis
optical coherence tomography

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014