Back to resultsCatheter-Based Treatment of Cardiovascular Disease
Primary Purpose
Obstructive Coronary Artery Disease, Obstructive Peripheral Artery Disease, Structural Heart Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Percutaneous Transluminal Angioplasty
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Coronary Artery Disease focused on measuring Angioplasty, Stent, Coronary Artery Disease, Peripheral Artery Disease, Percutaneous Coronary Intervention, CAD, PAD, Cardiovascular Disease
Eligibility Criteria
- INCLUSION CRITERIA:
Adult men and women with cardiovascular disease will be eligible to participate in this training protocol.
- Adult men and women, age 18 years or older
Eligible for catheter-based treatment. A representative list of diseases and catheter-based treatments includes:
- Obstructive coronary artery disease manifest as myocardial infarction, angina pectoris, angina-equivalent, ischemic dysrhythmia, or evidence of ischemia or viability on non-invasive cardiovascular testing
- Obstructive peripheral artery disease manifest as intermittent claudication, limb-threatening ischemia, visceral ischemia, or obstructive extracranial cerebrovascular disease
- Structural heart disease including patent foramen ovale, atrial septal defect, ventricular septal defect, patent ductus arteriosus, and valvular heart disease
EXCLUSION CRITERIA:
Subjects are excluded if catheter-based therapy is unsuitable, in the opinion of the operating cardiologist.
- Pregnant women
- Inability of patient or surrogate to provide informed consent.
Sites / Locations
- National Heart, Lung and Blood Institute (NHLBI), 9000 Rockville Pike
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00380016
First Posted
September 22, 2006
Last Updated
June 30, 2017
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00380016
Brief Title
Catheter-Based Treatment of Cardiovascular Disease
Official Title
Catheter-Based Treatment of Cardiovascular Disease in Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 3, 2009
Overall Recruitment Status
Completed
Study Start Date
September 20, 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 3, 2009 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
This study offers catheter-based treatment of heart or artery disease. This protocol permits treatment of patients with cardiovascular diseases who may not be eligible to participate in current research protocols. The treatment offered in this protocol is not experimental, but rather standard treatment provided in most large referral hospitals in the United States.
Patients 18 years of age and older who are candidates for catheter-based treatment of obstructive artery disease, including blocked blood flow in a coronary artery (artery to the heart) or in an artery of the arm, leg, brain or kidney may be eligible for this study. Candidates are screened with a general medical evaluation that may include blood tests, magnetic resonance imaging, and monitoring of heart rate and rhythm.
Participants undergo angioplasty or stenting for blockage in an artery to the heart or an artery of the arm, leg, brain or kidney. The procedure uses a balloon-tipped catheter to open the blocked artery and likely requires permanent implantation of a metal tube (stent) to improve blood flow through the vessel. During the procedure, the patient is given a sedative and pain medication, if needed.
Detailed Description
The NHLBI is developing novel minimally invasive catheter-based treatments for cardiovascular disease. These investigational treatments require that physicians, nurses and technical staff maintain and expand their technical skills in the conduct of conventional catheter-based treatments.
This protocol permits treatment of patients with cardiovascular diseases who are not necessarily eligible to participate in existing clinical research protocols, but who are of medical interest for the purpose of training professional staff, or who may be eligible for adjunctive investigational imaging during clinical treatment. Efforts will be made to offer treatment to patients with limited financial resources or with limited access to specialty health care.
This protocol also provides a mechanism to offer catheter-based treatment of cardiovascular disease to patients, so that they may participate in technical development protocols in cardiovascular intervention or in cardiovascular imaging.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Coronary Artery Disease, Obstructive Peripheral Artery Disease, Structural Heart Disease
Keywords
Angioplasty, Stent, Coronary Artery Disease, Peripheral Artery Disease, Percutaneous Coronary Intervention, CAD, PAD, Cardiovascular Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Transluminal Angioplasty
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA:
Adult men and women with cardiovascular disease will be eligible to participate in this training protocol.
Adult men and women, age 18 years or older
Eligible for catheter-based treatment. A representative list of diseases and catheter-based treatments includes:
Obstructive coronary artery disease manifest as myocardial infarction, angina pectoris, angina-equivalent, ischemic dysrhythmia, or evidence of ischemia or viability on non-invasive cardiovascular testing
Obstructive peripheral artery disease manifest as intermittent claudication, limb-threatening ischemia, visceral ischemia, or obstructive extracranial cerebrovascular disease
Structural heart disease including patent foramen ovale, atrial septal defect, ventricular septal defect, patent ductus arteriosus, and valvular heart disease
EXCLUSION CRITERIA:
Subjects are excluded if catheter-based therapy is unsuitable, in the opinion of the operating cardiologist.
Pregnant women
Inability of patient or surrogate to provide informed consent.
Facility Information:
Facility Name
National Heart, Lung and Blood Institute (NHLBI), 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Catheter-Based Treatment of Cardiovascular Disease
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