Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00380016
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-09-22
Brief Title:
Catheter-Based Treatment of Cardiovascular Disease
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Catheter-Based Treatment of Cardiovascular Disease in Patients
Status:
COMPLETED
Status Verified Date:
2009-03-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-H-0203 | None | None | None |