In-stent Coronary Artery RestenosisNCT01835301
Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation
An observational study of In-stent Coronary Artery Restenosis, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
This study aims to test the hypothesis that plaque composition differs within a stent between bare metal stents and drug eluting stents (DES). It is possible that a difference in plaque composition seen within a stent may be contributory to the late thrombotic events seen more frequently with DES. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- In-stent Coronary Artery Restenosis
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Dec 2015
- Phase
- Observational
- 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
Study population: A total of 40 subjects will be enrolled in the study, with 20 patients who previously received BMS > 3 years ago and 20 patients who previously received DES > 3 years ago
Who may be able to join
- Subject > 18 years of age;
- Subject, male or female, who underwent DES or BMS implantation in a native coronary vessel more than 3 year ago;
- Subject is scheduled for a diagnostic coronary or interventional procedure;
- Subject is willing to sign the informed consent.
Who cannot join
- Subject requires emergency catheterization;
- Subject has an acute myocardial infarction defined as anginal symptoms with ST-elevation on the EKG or creatine kinase-MB elevation >3times the upper limit of normal;
- Angiographic evidence of ≥ 70% stenosis within the target stent (visual estimate);
- Subject presented with cardiogenic shock;
- Subject has angiographically confirmed thrombus in the target coronary artery;
- Subject has a complex lesion not amenable to the IVUS/VH catheters and/or OCT catheters passing the stented segment;
Show all 9Show fewer
- Subject has a contraindication to angiography/IVUS/OCT;
- Female subject is pregnant or lactating;
- Subject has life threatening comorbid conditions for which the investigator feels the subject should not be enrolled
Trial locations and contacts
1 site in 1 country.
United States1 site
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
This study aims to test the hypothesis that plaque composition differs within a stent between bare metal stents and drug eluting stents (DES). It is possible that a difference in plaque composition seen within a stent may be contributory to the late thrombotic events seen more frequently with DES.
- Conditions
- In-stent Coronary Artery Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DES | Patients who received a DES stent > 3 years ago. | |
| BMS | Patients who received BMS stents > 3 years ago. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque composition
This study aims to test the hypothesis that plaque composition differs within the stent between BMS and DES. It is possible that a difference in plaque composition seen within the stent may be contributory to the late thrombotic events seen more frequently with DES.
Measured: During hospital stay, about 2 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startNov 2011
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In-stent Coronary Artery RestenosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ron Waksman, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835301
- Sponsor's protocol ID
- IntraStent
- Status last verified
- Aug 2014
- First submitted
- 12 Apr 2013
- Last updated
- 11 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation
- ClinicalTrials.gov ID
- NCT01835301
- Acronym / sponsor ID
- IntraStent
- Conditions
- In-stent Coronary Artery Restenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2015 (estimated)
- First posted
- 18 Apr 2013 (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 aims to test the hypothesis that plaque composition differs within a stent between bare metal stents and drug eluting stents (DES). It is possible that a difference in plaque composition seen within a stent may be contributory to the late thrombotic events seen more frequently with DES.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DES | – | –Patients who received a DES stent > 3 years ago. |
| BMS | – | –Patients who received BMS stents > 3 years ago. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 40 subjects will be enrolled in the study, with 20 patients who previously received BMS > 3 years ago and 20 patients who previously received DES > 3 years ago
Key inclusion criteria (4 listed)
- Subject > 18 years of age;
- Subject, male or female, who underwent DES or BMS implantation in a native coronary vessel more than 3 year ago;
- Subject is scheduled for a diagnostic coronary or interventional procedure;
- Subject is willing to sign the informed consent.
Key exclusion criteria (9 listed)
- Subject requires emergency catheterization;
- Subject has an acute myocardial infarction defined as anginal symptoms with ST-elevation on the EKG or creatine kinase-MB elevation >3times the upper limit of normal;
- Angiographic evidence of ≥ 70% stenosis within the target stent (visual estimate);
- Subject presented with cardiogenic shock;
- Subject has angiographically confirmed thrombus in the target coronary artery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plaque composition
Time frame: During hospital stay, about 2 days.
This study aims to test the hypothesis that plaque composition differs within the stent between BMS and DES. It is possible that a difference in plaque composition seen within the stent may be contributory to the late thrombotic events seen more frequently with DES.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
Related trials for In-stent Coronary Artery Restenosis
Recruiting
Virtue® SAB in the Treatment of Coronary ISR Trial
Coronary Artery Disease
Recruiting
Prevail Global Study
Coronary Artery Disease
Active, not recruiting
SELUTION SLR™ 014 In-stent Restenosis
Coronary Restenosis
RecruitingObservational study
Real-World Outcomes of Drug-Coated Balloon Angioplasty in Coronary Artery Disease
Coronary Artery Disease
Recruiting
First-in-Human Study Using the SiroMax™ Sirolimus-Coated Balloon Catheter as a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to Treat Subjects Who Have Coronary Artery Disease (CAD) Involving In-Stent Restenosis (ISR) or an Unstented Lesion in a Small Coronary Vessel (DNSV).
Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
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.
Ron Waksman, MD principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of In-stent Coronary Artery Restenosis, run by Medstar Health Research Institute 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 11 Aug 2014. 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?
Results are not available in the source record.
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.
What does the primary outcome measure?
Plaque composition (time frame: During hospital stay, about 2 days.). It is what the study was designed to measure, not a finding.
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 11 Aug 2014.