In-hospital and Long-term Outcomes for Percutaneous Chronic Total Coronary Occlusion Revascularization in a High-volume, Multi-operator Program

NCT01946724 | Completed

• 1 other identifier: Perspective
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to study whether percutaneous chronic total occlusion (CTO) revascularization, by the use of Percutaneous Coronary Intervention (PCI), stenting, guidewire, and catheter, improves a patient's quality of life and their left ventricular function, reduces angina severity, and improves long-term survival.

Conditions

Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• CTO procedural success

  CTO procedural success as defined by an achievement of a final residual angiographic stenosis \< 50% within the treated segment with \>=TIMI 2 antegrade flow.

  1 year

Secondary Outcomes (2)

• Major Adverse Cardiac Events (MACE)

  Prior to Index Hospitalization Discharge (< 1 year from procedure)

• Clinical Outcomes

  1 year

Other Outcomes (1)

• MACE

  1 year

Eligibility Criteria

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

Study Population

Subjects experiencing clinical symptoms considered suggestive of ischemic heart disease or having evidence of myocardial ischemia who have had or are scheduled to have percutaneous chronic total occlusion (CTO) revasulcarization by Percutaneous Coronary Intervention (PCI)

You may qualify if:

• The subject is \> 18 years of age at the time of consent
• Subjects experiencing clinical symptoms considered suggestive of ischemic heart disease (eg, chest pain or discomfort or symptoms considered by the investigator to represent anginal equivalents) or having evidence of myocardial ischemia (eg, abnormal functional study) attributed to the CTO target vessel and scheduled for clinically indicated percutaneous CTO revascularization or are subjects with multi-vessel disease and/or Acute Coronary Syndrome (ACS) that are undergoing a staged CTO PCI procedure with the intent to achieve complete revascularization.
• Subject must have at least 1 target segment meeting non-acute total coronary occlusion as defined below. A CTO is any non-acute total coronary occlusion fulfilling the following angiographic characteristics and:
• High-grade native coronary stenosis
• Thrombolysis in Myocardial Infarction (TIMI) 0 or 1 antegrade flow
• Estimated in duration at least 3 months by clinical history and/or comparison with antecedent angiogram, functional study or electrocardiogram
• CTO segment may be de novo or previously treated via PCI
• Subject is eligible and consents to undergo or has undergone a PCI procedure
• Subject is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA) and stenting.
• Subject is willing and able to provide informed consent as approved by local Institutional Review Board/Ethics Committee and to complete the protocol requirements for the study.
• Female subjects of child-bearing potential with a negative qualitative or quantitative pregnancy test in accordance to the Piedmont Hospital Policy.

You may not qualify if:

• Any known allergy, hypersensitivity or contraindication to iodinated contrast that cannot be effectively managed medically
• Any known allergy, hypersensitivity or contraindication to clopidogrel bisulfate (Plavix®), prasugrel (Effient®) or ticagrelor (Brilinta®)-- for which alternative agents cannot be used-- or aspirin, heparin, nickel, stainless steel, zotarolimus, or everolimus
• Any contraindication to cardiac catheterization or to any of the standard concomitant therapies used during routine cardiac catheterization and PCI
• Subjects with any other pathology or indication which in the opinion of the investigator, might put the subject at risk, preclude follow-up, or in any way confound the results of the study
• Known previous medical condition yielding expected survival less than one year
• Subjects who are unable or unwilling to comply with the protocol or not expected to complete the study period, including its follow-up requirements
• Subjects with evidence of ongoing or active clinical instability including any of the following:
• Sustained systolic blood pressure \< 100 mmHg (if different from baseline) or cardiogenic shock
• Acute pulmonary edema that has not been medically stabilized
• Suspected acute myocarditis, pericarditis, endocarditis, or cardiac tamponade
• Suspected dissecting aortic aneurysm
• Subjects with known clinically significant abnormal laboratory findings including:
• White Blood Cells (\<1,000 WBC/mm3)
• Thrombocytopenia (\<100,000 platelets/mm3)
• Subjects with history of bleeding diathesis or coagulapathy or refusal of blood transfusions

Sponsors & Collaborators

• Piedmont Healthcare: lead

Study Sites (1)

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• David Kandzari, MD

  Piedmont Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: September 20, 2013
• Study Start: August 1, 2013
• Primary Completion: May 24, 2017
• Study Completion: May 24, 2017
• Last Updated: April 2, 2019

Record last verified: 2019-03

Locations

US (1)