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A Prospective, Multi-center, Non-Randomized, Single-arm, Open-label Study of Percutaneous Coronary Intervention in Community Hospitals Without Cardiac Surgery-On-Site

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

The primary objective of the Post-Randomization Phase Cohort Study is to continue to assess the safety of non-emergency PCI performed at hospitals without cardiac surgery on-site in patients with myocardial ischemia (other than ST-segment elevation myocardial infarction [STEMI]).

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

Inclusion Criteria:

Candidates for this study must meet ALL of the following criteria:

- Subject is at least 18 years old.

- Subject requires single- or multi-vessel percutaneous coronary intervention (PCI) of
de novo or restenotic target lesion (including in-stent restenotic lesions). N.B.
staged procedure will not be considered to meet the endpoint component of repeat
revascularization if either of the following pre-catheterization procedure qualifying
clinical laboratory values are met:

- eGFR is less than 60 ml/min or

- creatinine is greater than 1.5 mg/dl

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

- Subject is an acceptable candidate for non-emergency, urgent or emergency CABG.

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

- 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.

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

- Subject has been informed of the nature and purpose 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.

Angiographic Inclusion Criteria

- The target lesion(s) is (are) de novo or restenotic (including in-stent restenotic)
native coronary artery lesion(s) with greater or equal to 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.

- If Fractional Flow Reserve (FFR) is measured, target lesion(s) has (have) evidence of
a hemodynamically significant stenosis determined by FFR measurement (FFR less than
or equal to 0.8).

- 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)
greater than 72 hours following the STEMI.

Lesions treated with PCI greater 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:

Subjects will be excluded from participation in the Cohort Study (and non-emergency PCI
may not be performed in these patients at the non-SOS site) if ANY of the following
conditions apply:

- The patient is pregnant or breastfeeding.

- Evidence of ST segment elevation myocardial infarction within 72 hours of the
intended treatment on infarct related or non-infarct related artery.

- Cardiogenic shock on presentation or during current hospitalization.

- Left ventricular ejection fraction less than 20%.

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

- 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.

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

- 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).

- Prior participation in the MASS-COMM Trial, unless the patient has completed the
12-month follow-up for the Trial, and/or prior participation in the Cohort Study,
unless the patient has completed the 30-day follow-up for the Cohort Study.

- Within 30 days prior to the index Cohort 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.

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

- Active peptic ulcer or upper GI bleeding within the prior 3 months.

- Subject has active sepsis.

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

- Subject has evidence of a hemodynamically insignificant stenosis determined by FFR
measurement (FFR greater than 0.8).

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

Angiographic Exclusion Criteria

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

- Any target vessel has evidence of:

1. excessive thrombus (e.g., requires target vessel thrombectomy)

2. tortuosity (greater than 60 degree angle) that makes it unsuitable for proper
stent delivery and deployment,

3. heavy calcification.

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

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

- The target vessel is in a "last remaining" epicardial vessel (e.g., >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
  • Laura Mauri, MD
  • Sharon-Lise Normand, PhD
Trial Interventions
Procedure
  • PCI
Physician Researcher

Investigator Name:

  • Alice K Jacobs, MD
  • Laura Mauri, MD
  • Sharon-Lise Normand, PhD

Other Information

Sponsor: Harvard Clinical Research Institute
Phase: N/A
Trial ID: NCT02072421
Volunteers:  Not Accepting Healthy Volunteers

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