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Catheter-Based Treatment of Cardiovascular Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00380016
First Posted: September 25, 2006
Last Update Posted: July 2, 2017
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.
Information provided by:
National Institutes of Health Clinical Center (CC)
  Purpose

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.


Condition Intervention
Obstructive Coronary Artery Disease Obstructive Peripheral Artery Disease Structural Heart Disease Procedure: Percutaneous Transluminal Angioplasty

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Catheter-Based Treatment of Cardiovascular Disease in Patients

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 150
Study Start Date: September 20, 2006
Estimated Study Completion Date: March 3, 2009
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Adult men and women with cardiovascular disease will be eligible to participate in this training protocol.

  1. Adult men and women, age 18 years or older
  2. 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.

  1. Pregnant women
  2. Inability of patient or surrogate to provide informed consent.
  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): NCT00380016


Locations
United States, Maryland
National Heart, Lung and Blood Institute (NHLBI), 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
  More Information

ClinicalTrials.gov Identifier: NCT00380016     History of Changes
Other Study ID Numbers: 060203
06-H-0203
First Submitted: September 22, 2006
First Posted: September 25, 2006
Last Update Posted: July 2, 2017
Last Verified: March 3, 2009

Keywords provided by National Institutes of Health Clinical Center (CC):
Angioplasty
Stent
Coronary Artery Disease
Peripheral Artery Disease
Percutaneous Coronary Intervention
CAD
PAD
Cardiovascular Disease

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