Rapid Inflation/Deflation Compared With Prolonged High-Pressure Balloon Inflation

NCT01952873 | Not Yet Recruiting

• 1 other identifier: 287332
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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 malposition 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.

Conditions

Coronary Artery Disease; Coronary Stent Occlusion

Keywords

stents; angioplasty, balloon, coronary; coronary artery stenosis; optical coherence tomography

Outcome Measures

Primary Outcomes (3)

• Number of unopposed stent struts

  How many stents are unopposed

  Day 1 Within first hour after after stent deployment

• Minimal luminal stent area

  Minimal area of the luminal stent area measured

  Day 1 Within first hour after after stent deployment

• Minimal lumen stent diameter

  Diameter measured

  Day 1 Within first hour after after stent deployment

Secondary Outcomes (4)

• Number of unopposed stent struts/mm of stent

  Day 1 Within first hour after stent deployment

• % of patients with complete stent apposition

  Day 1 Within first hour after stent deployment

• Symptomatic ischemia requiring balloon deflation

  Intra-procedure

• Serious arrhythmia

  Intra-procedure and first hour post-Percutaneous Coronary Intervention (PCI)

Study Arms (2)

Rapid

ACTIVE COMPARATOR

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

Prolonged

EXPERIMENTAL

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

Interventions

Prolonged inflation OTHER

Prolonged inflation will be performed at high pressure(16 atm)and maintained for 30 sec with \<0.3 atm drop during that period.

Prolonged

Rapid inflation OTHER

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.

Rapid

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Central Arkansas Veterans Healthcare System: lead

Study Sites (1)

John L. McClellan Memorial Veterans Hospital

Little Rock, Arkansas, 72205, United States

Location

Related Publications (1)

• Cook JR, Mhatre A, Wang FW, Uretsky BF. Prolonged high-pressure is required for optimal stent deployment as assessed by optical coherence tomography. Catheter Cardiovasc Interv. 2014 Mar 1;83(4):521-7. doi: 10.1002/ccd.24724. Epub 2013 Feb 21.

  PMID: 23436559 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Barry F Uretsky, M.D.

  Central Arkansas Veterans' Healthcare System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristin Miller, RN

CONTACT

501-257-5893; kristin.miller4@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: September 30, 2013
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 17, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)