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Trial record 3 of 217 for:    heart disease AND stroke AND California

Safety and Efficacy of PCI at California Hospitals Without Onsite Cardiac Surgery (PCI-CAMPOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02022345
Recruitment Status : Completed
First Posted : December 27, 2013
Last Update Posted : May 30, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Coronary Artery Disease Procedure: Percutaneous Coronary Intervention

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5609 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PCI California Audit Monitored Pilot With Offsite Surgery
Study Start Date : August 2010
Primary Completion Date : December 2014
Study Completion Date : February 2015

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: PCI at pilot hospitals
Percutaneous Coronary Interventions performed at pilot hospitals which do not have onsite cardiac surgery.
Procedure: Percutaneous Coronary Intervention
Other Name: Coronary Angioplasty, Simple Angioplasty
Active Comparator: PCI at non-pilot hospitals
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
Other Name: Coronary Angioplasty, Simple Angioplasty


Outcome Measures

Primary Outcome Measures :
  1. Composite safety endpoint (death, stroke, need for emergent CABG) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days. ]
    The number of subjects who had death, stroke or a need emergent CABG as a result of having PCI procedure performed.


Secondary Outcome Measures :
  1. Composite efficacy endpoint (<20% residual stenosis and post TIMI-3 flow) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days. ]
    The number of lesions treated that resulted in both a residual lesion stenosis of less than 20% and post procedure TIMI-3 flow.

  2. AOC composite endpoint (in-hospital death and/or need for emergent CABG) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days. ]
    The number of subjects who had death or a need emergent CABG as a result of having PCI procedure performed.


Other Outcome Measures:
  1. In-hospital death [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days. ]
    Number of patients who expired during the current hospital admission.

  2. Stroke [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days. ]
    Number of patients diagnosed with new onset post-PCI stroke during the current hospital admission.

  3. Need for emergent CABG [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days. ]
    Number of patients that needed emergent CABG post-PCI during current hospital admission.

  4. <20% residual stenosis [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days. ]
    Number of lesions treated with less than 20% residual lesion stenosis post-PCI.

  5. post TIMI-3 flow [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days. ]
    Number of lesions treated with TIMI-3 flow post PCI procedure.


Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02022345


Locations
United States, California
Clovis Community Medical Center
Clovis, California, United States, 93611
St Rose Hospital
Hayward, California, United States, 94545
Los Alamitos Medical Center
Los Alamitos, California, United States, 90720
Sutter Roseville Medical Center
Roseville, California, United States, 95661
Doctors Medical Center
San Pablo, California, United States, 94806
Kaiser Foundation Hospital Walnut Creek
Walnut Creek, California, United States, 94596
Sponsors and Collaborators
University of California, Davis
Clovis Community Hospital
Doctors Medical Center
Kaiser Foundation Hospital Walnut Creek
Los Alamitos Medical Center
St. Rose Hospital
Sutter Roseville Medical Center
Investigators
Principal Investigator: 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 Foundation Hospital Walnut Creek
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
More Information

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02022345     History of Changes
Other Study ID Numbers: 301136
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by University of California, Davis:
Percutaneous Coronary Intervention
Coronary Artery Disease
Angioplasty
Offsite cardiac surgery
Heart disease
Ischemic Heart Disease

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