Ultrasound Comparison of Radial Artery Hyperplasia After Use of a 7F Sheathless Guide vs. 6F Sheath/Guide Combination

NCT03271177 | Completed

• 1 other identifier: 2016-04
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine if the routine use of a sheathless 7F guide catheter for transradial percutaneous coronary intervention (TR PCI) is non-inferior to a 6F sheath/guide combination with regards to radial artery injury (radial artery intimal-medial-adventitial thickening). To evaluate the radial artery, ultrahigh resolution ultrasonography (55 mHz) will be used to accurately quantify radial artery intimal-medial-adventitial thickness (IMT) at baseline and 90 days. A non-inferiority analysis will be performed to compare the degree of radial artery IMT at 90 days between the 7F sheathless guide approach and the 6F sheath/guide combination.

Conditions

Coronary Artery Disease

Keywords

transradial percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• Radial artery access site intimal-medial thickness (IMT)

  The incidence of other vascular complications such as radial artery occlusion, pseudo-aneurysms, radial artery diameter, and radial artery dissections will also be assessed.

  90-day

Secondary Outcomes (5)

• Procedural Success Rate

  up to 24 hours

• Major Adverse Cardiac Events (MACE)

  from date of PCI until date of death, MI or urgent revascularization, whichever came first, assessed up to 72 hrs

• Fluoroscopy Time

  During PCI procedure (from beginning of procedure until end)

• Number of Guide Catheters Used

  During PCI procedure (from beginning of procedure until end)

• Frequency of Cross-over from Radial Access to Femoral Access

  During PCI procedure (from beginning of procedure until end)

Study Arms (2)

7F Sheathless Guide Catheter

EXPERIMENTAL

Patients in this arm will undergo their percutaneous coronary intervention using a 7F Sheathless guide catheter

Device: 7F sheathless Guide Catheter

6F Sheath/Guide Catheter Combination

PLACEBO COMPARATOR

Patients in this arm will undergo their percutaneous coronary intervention using a 6F Sheath/guide combination

Device: 6F Sheath/Guide Catheter Combination

Interventions

7F sheathless Guide Catheter DEVICE

Transradial PCI will be performed with a 7F sheathless Guide Catheter

7F Sheathless Guide Catheter

6F Sheath/Guide Catheter Combination DEVICE

Transradial PCI will be performed with a 6F Sheath/Guide Catheter Combination

6F Sheath/Guide Catheter Combination

Eligibility Criteria

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

You may qualify if:

• Age 18 or above with coronary artery disease
• Scheduled for transradial PCI

You may not qualify if:

• Has had prior transradial access for heart catheterization or PCI in same radial artery as planned access site
• Not willing to undergo follow-up ultrasound examinations
• Acute ST elevation myocardial infarction or other emergent PCI
• Inability to provide informed consent

Sponsors & Collaborators

• Tallahassee Research Institute, Inc.: lead
• Boston Scientific Corporation: collaborator

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Wayne B Batchelor, MD, MHS

  Tallahassee Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: September 1, 2017
• Study Start: February 25, 2016
• Primary Completion: March 13, 2017
• Study Completion: March 13, 2017
• Last Updated: September 1, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share