Safety and Efficacy of PCI at California Hospitals Without Onsite Cardiac Surgery

NCT02022345 | Completed DMC

• 1 other identifier: 301136
• Study Type: interventional
• Target: 5,609
• Locations: 1 country
• Sites: 6

Brief Summary

To evaluate the introduction of Percutaneous Coronary Intervention without Onsite Surgery in the largest state, California (CA) began a pilot PCI program in 6 hospitals without onsite cardiac surgery and then compared the PCI results in the pilot hospitals with results in 120 non-pilot hospitals. The pilot program qualification incorporated appropriate planning and rigorous hospital, operator, patient, and lesion selection criteria.

Conditions

Coronary Artery Disease

Keywords

Percutaneous Coronary Intervention; Coronary Artery Disease; Angioplasty; Offsite cardiac surgery; Heart disease; Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• Composite safety endpoint (death, stroke, need for emergent CABG)

  The number of subjects who had death, stroke or a need emergent CABG as a result of having PCI procedure performed.

  participants will be followed for the duration of hospital stay, an expected average of 3 days.

Secondary Outcomes (2)

• Composite efficacy endpoint (<20% residual stenosis and post TIMI-3 flow)

  participants will be followed for the duration of hospital stay, an expected average of 3 days.

• AOC composite endpoint (in-hospital death and/or need for emergent CABG)

  participants will be followed for the duration of hospital stay, an expected average of 3 days.

Other Outcomes (5)

• In-hospital death

  participants will be followed for the duration of hospital stay, an expected average of 3 days.

• Stroke

  participants will be followed for the duration of hospital stay, an expected average of 3 days.

• Need for emergent CABG

  participants will be followed for the duration of hospital stay, an expected average of 3 days.

Study Arms (2)

PCI at pilot hospitals

ACTIVE COMPARATOR

Percutaneous Coronary Interventions performed at pilot hospitals which do not have onsite cardiac surgery.

Procedure: Percutaneous Coronary Intervention

PCI at non-pilot hospitals

ACTIVE COMPARATOR

Percutaneous Coronary Intervention performed at non-pilot hospitals which have onsite cardiac surgery or perform only primary PCIs for STEMI patients.

Procedure: Percutaneous Coronary Intervention

Interventions

Percutaneous Coronary Intervention PROCEDURE

Also known as: Coronary Angioplasty, Simple Angioplasty

PCI at non-pilot hospitals; PCI at pilot hospitals

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• clinically and angiographically significant coronary artery disease
• ability to perform PCI with equipment available at the local site
• not high-risk patient with a not high-risk lesion
• not high-risk patient with a high-risk lesion
• high-risk patient with a not high-risk lesion may be included in the pilot program upon confirmation that a cardiac surgeon and an operating room are immediately available if necessary

You may not qualify if:

• high-risk patient with a high-risk lesion
• need for coronary artery bypass surgery

Sponsors & Collaborators

• University of California, Davis: lead
• Clovis Community Hospital: collaborator
• Doctors Medical Center: collaborator
• Kaiser Permanente: collaborator
• Los Alamitos Medical Center: collaborator
• St. Rose Hospital: collaborator
• Sutter Roseville Medical Center: collaborator

Study Sites (6)

Clovis Community Medical Center

Clovis, California, 93611, United States

Location

St Rose Hospital

Hayward, California, 94545, United States

Location

Los Alamitos Medical Center

Los Alamitos, California, 90720, United States

Location

Sutter Roseville Medical Center

Roseville, California, 95661, United States

Location

Doctors Medical Center

San Pablo, California, 94806, United States

Location

Kaiser Foundation Hospital Walnut Creek

Walnut Creek, California, 94596, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Heart Diseases; Myocardial Ischemia

Interventions

Percutaneous Coronary Intervention; Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Coronary Disease; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Angioplasty; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• William J Bommer, MD

  UC Davis Health System

  PRINCIPAL INVESTIGATOR

• Rohit Sundrani, MD

  Clovis Community Medical Center

  PRINCIPAL INVESTIGATOR

• Stephen Arnold, MD

  Doctors Medical Center, San Pablo

  PRINCIPAL INVESTIGATOR

• Sushil Karmarkar, MD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

• Steven Forman, MD

  Los Alamitos Medical Center

  PRINCIPAL INVESTIGATOR

• Aditya Jain, MD

  St Rose Hospital, Hayward

  PRINCIPAL INVESTIGATOR

• George Fehrenbacher, MD

  Sutter Roseville Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 27, 2013
• Study Start: August 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

US (6)