NOT_YET_RECRUITING
Rapid Inflation/Deflation Compared With Prolonged High-Pressure Balloon Inflation
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.
Conditions:
🦠 Coronary Artery Disease 🦠 Coronary Stent Occlusion
🗓️ Study Start (Actual) January 2024
🗓️ Primary Completion (Estimated) December 2028
✅ Study Completion (Estimated) December 2028
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Little Rock, Arkansas, United States

📋 Eligibility Criteria

Description

    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
    • -
Ages Eligible for Study: 19 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 September 2013
  • First Submitted that Met QC Criteria 25 September 2013
  • First Posted 30 September 2013

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 February 2023
  • Last Update Posted 10 February 2023
  • Last Verified February 2023