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A Randomized Trial to Compare Percutaneous Coronary Intervention Between Massachusetts Hospitals With Cardiac Surgery-On-Site and Community Hospitals Without Cardiac Surgery-On-Site

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Trial Conditions
  • Coronary Artery Diseases
What is the purpose of this trial?

The primary objective of the trial is to compare the acute safety and long term outcomes between hospitals with cardiac surgery on-site (SOS hospitals) and hospitals without cardiac surgery on-site (non-SOS hospitals) for patients with ischemic heart disease treated with elective percutaneous coronary intervention (PCI) (stable angina, acute coronary syndrome, or non-Q wave MI) presenting to non-SOS hospitals.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

Inclusion Criteria:

1. Subject is at least 18 years old.

2. Subject requires single- or multi-vessel percutaneous coronary intervention (PCI) of
de novo or restenotic target lesion (including in-stent restenotic lesions).

3. Subject's lesion(s) is (are) amenable to stent treatment with currently available
FDA-approved bare metal or drug eluting stents.

4. Subject is an acceptable candidate for elective, urgent or emergency coronary artery
bypass graft (CABG).

5. Subject has clinical evidence of ischemic heart disease in terms of a positive
functional study, or documented symptoms.

6. Documented stable angina pectoris [Canadian Cardiovascular Society Classification
(CCS) 1, 2, 3, or 4], unstable angina pectoris with documented ischemia (Braunwald
Class IB-C, IIB-C, or IIIB-C), non-ST segment elevation myocardial infarction, or
documented silent ischemia.

7. Subject is willing and able to undergo percutaneous intervention at SOS hospital, if
randomized to SOS study arm.

8. Subject and the treating physician agree that the subject will comply with all
follow-up evaluations.

9. Subject has been informed of the nature of the study and agrees to its provisions and
has provided written informed consent as approved by the Institutional Review
Board/Ethics Committee of the respective clinical site.

10. The target lesion(s) is (are) de novo or restenotic (including in-stent restenotic)
native coronary artery lesion(s) with greater than 50 and less than 100% stenosis
(visual estimate), or the target lesion is an acute (less than 1 month) total
occlusion as evidenced by clinical symptoms.

11. Target lesions(s) is (are) located in an infarct (if not treated with primary PCI) or
non-infarct-related artery with a 70% or greater stenosis (by visual estimate) more
than 72 hours following the ST segment elevation myocardial infarction (STEMI).

Lesions treated with PCI more than 72 hours following STEMI would be subject to the same
protocol inclusion/exclusion criteria listed above and below with the exception that a
target lesion of 70% or greater stenosis may be treated with or without symptoms or
abnormal stress test).

Exclusion Criteria:

1. The patient is pregnant or breastfeeding.

2. Evidence of STEMI within 72 hours of the intended treatment on infarct related or
non-infarct related artery.

3. Cardiogenic shock on presentation or during current hospitalization.

4. Left ventricular ejection fraction less than 20%.

5. Known allergies to: aspirin, clopidogrel (Plavix) and ticlopidine (Ticlid), heparin,
bivalirudin, stainless steel, or contrast agent (which cannot be adequately
premedicated).

6. A platelet count less than 75,000 cells/mm3 or greater than 700,000 cells/mm3 or a
WBC less than 3,000 cells/mm3.

7. Acute or chronic renal dysfunction (creatinine greater than 2.5 mg/dl or less than
150µmol/L).

8. Subject is currently participating in an investigational drug or device study that
has not completed the primary endpoint or that clinically interferes with the current
study endpoints. (Note: Trials requiring extended follow-up for products that were
investigational, but have since become commercially available, are not considered
investigational trials).

9. Prior participation in this study.

10. Within 30 days prior to the index study procedure, the subject has undergone a
previous coronary interventional procedure of any kind. Note: This exclusion
criterion does not apply to post-STEMI patients.

11. Stroke or transient ischemic attack within the prior 3 months.

12. Active peptic ulcer or upper gastrointestinal bleeding within the prior 3 months.

13. Subject has active sepsis.

14. Unprotected left main coronary artery disease (stenosis greater than 50%).

15. In the investigator's opinion, subject has a co-morbid condition(s) that could limit
the life expectancy to less than one year, or limit the subject's ability to
participate in the study or comply with follow-up requirements or impact the
scientific integrity of the study.

16. Subject has normal or insignificant coronaries (i.e. coronary lesion(s) less than 50%
stenosis).

17. Any target vessel has evidence of:

- excessive thrombus (e.g. requires target vessel thrombectomy)

- tortuousity (greater than 60 degree angle) that makes it unsuitable for proper
stent delivery and deployment,

- heavy calcification.

18. Any target lesion requires treatment with a device other than percutaneous
transluminal coronary angioplasty (PTCA) prior to stent placement (e.g. but not
limited to, directional coronary atherectomy, excimer laser, rotational atherectomy,
etc.).

19. Any lesion that is located in a saphenous vein graft, however, lesions located within
the native vessel but accessed through the graft are eligible.

20. The target vessel is in a "last remaining" epicardial vessel (e.g. greater than 2
non-target epicardial vessels and the bypass grafts to these territories [if present]
are totally occluded).

Gender: Both
Steward Physician(s)
  • Alice K Jacobs, MD
  • Sharon-Lise Normand, Ph.D.
  • Laura Mauri, M.D.
Facilities
  • Good Samaritan Medical Center - Completed
  • Holy Family Hospital - Completed
  • Norwood Hospital - Completed
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
Procedure
  • PCI
Physician Researcher

Investigator Name:

  • Alice K Jacobs, MD
  • Sharon-Lise Normand, Ph.D.
  • Laura Mauri, M.D.

Other Information

Sponsor: Harvard Clinical Research Institute
Phase: N/A
Trial ID: NCT01116882
Volunteers:  Not Accepting Healthy Volunteers

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