Obstructive Coronary Artery DiseaseNCT00380016
Catheter-Based Treatment of Cardiovascular Disease
A study testing Percutaneous Transluminal Angioplasty in people with Obstructive Coronary Artery Disease and Obstructive Peripheral Artery Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Coronary Artery Disease, Obstructive Peripheral Artery Disease, Structural Heart Disease
- What is being tested?
- Percutaneous Transluminal Angioplasty
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2006to 3 Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Heart, Lung and Blood Institute (NHLBI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Catheter-Based Treatment of Cardiovascular Disease in Patients
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.
Read the 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.
- Conditions
- Obstructive Coronary Artery Disease, Obstructive Peripheral Artery Disease, Structural Heart Disease
- Being tested
- Percutaneous Transluminal Angioplasty
- Keywords
- Angioplasty, Stent, Coronary Artery Disease, Peripheral Artery Disease, Percutaneous Coronary Intervention, CAD, PAD, Cardiovascular Disease
- Medical subject headings
- Coronary Artery Disease, Peripheral Arterial Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Transluminal AngioplastyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2006 (estimated)
- Study start20 Sep 2006
- Study completion3 Mar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Enrolment
- 150 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380016
- Sponsor's protocol ID
- 060203
- Other IDs
- 06-H-0203
- Status last verified
- 3 Mar 2009
- First submitted
- 22 Sep 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter-Based Treatment of Cardiovascular Disease in Patients
- ClinicalTrials.gov ID
- NCT00380016
- Acronym / sponsor ID
- 060203
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 20 Sep 2006
- Study completion
- 3 Mar 2009
- First posted
- 25 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Transluminal Angioplasty | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Transluminal Angioplasty in people with Obstructive Coronary Artery Disease and Obstructive Peripheral Artery Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.