In-Stent Coronary Artery RestenosisNCT03008772
REWARDS- In-stent Restenosis
An observational study of In-Stent Coronary Artery Restenosis, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
To define the long-term incidence and frequency of ISR follow DES implantation. Compare the clinical presentation, treatment and intervention success among de novo coronary artery stenosis and DES ISR. 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2018to Jan 2024
- How long will I take part?
- 5 Years
- 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: All study subjects will be identified retrospectively. Patients who have undergone PCI and received a commercially available drug eluting stent as listed above. These patients will be compared between the stent types for angina classification at follow up.
Who may be able to join
- Patients, male or female, > 18 years of age,
- Patients who received at least one (1) commercially available Drug Eluting Stent
Who cannot join
- none
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
Official title: REWARDS-In-stent Restenosis
To define the long-term incidence and frequency of ISR follow DES implantation. Compare the clinical presentation, treatment and intervention success among de novo coronary artery stenosis and DES ISR.
Compare short- and long-term outcomes of de novo coronary artery stenosis and DES ISR, assessed by incidence of mortality, MACE, MI, and TLR/TVR at index hospitalization, 30 days, 6 months, 1 year, 3 years, and 5 years, if available.
Read the detailed description
Drug-eluting coronary stents (DES) significantly reduced the rate of neointimal hyperplasia and in-stent restenosis (ISR) compared to bare metal stents (BMS) for the treatment of coronary artery disease. In addition, the continued evolution in scaffold and polymer design with concomitant improvements in antiplatelet therapy has improved the rates of late and very late stent thrombosis. However, despite novel metal scaffold technology, increasing operator experience, and improvement in adjunctive implantation techniques, the incidence of ISR in durable-polymer DES remains a problem, with 1-year rates as high as 12 to 15%.
The outcomes associated with ISR highlight the fact that this is by no means a benign process and studies report MI rates as high as 19.4% with one study demonstrating a total rate of death or nonfatal MI of 3.5%. In addition, ISR presenting as acute coronary syndrome (ACS) has an independent effect on major adverse cardiac events. The emergence of fully bioresorbable vascular scaffolds (BVS) has provided an exciting alternative to combat the long-term structural and functional effects on the coronary vessel seen with implantation of a permanent metal scaffold, regardless of the drug coating. Initial studies have demonstrated the non-inferiority of BVS compared to contemporary DES in regards to death, MI, and MACE. In addition, intravascular imaging has confirmed complete resorbtion of the BVS by 3 years time. The long-term benefits of such technology have yet to be fully assessed. However, based on literature outlining the complicated course of ISR in short-term and that seen in the bare metal stent era, it is projected that complete resorbtion of the vascular scaffold should improve long-term outcomes of patients with ischemic heart disease.
Currently, the clinical presentation, incidence, and outcomes of ISR in contemporary DES are not completely understood. The goal of this particular study is to retrospectively evaluate the long-term impact of ISR over a 10-year period in current contemporary DES. The data can be compared to de novo coronary artery lesions with similar characteristics and complexity to highlight the significant differences in the clinical course of each disease. Ultimately, the investigators will hopefully demonstrate the need for improvement in this arena, which the BVS will potentially provide.
- 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 |
|---|---|---|
| PCI with Commercially available DES | Patients who have undergone PCI and received a commercially available drug eluting stent | |
| Stent Types | the stent types for angina classification at follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Instent Restenosis
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startFeb 2018 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2024 (estimated)
Why it stopped: Not funded
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
- Other
- Enrolment
- 0 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008772
- Sponsor's protocol ID
- REWARDS-ISR
- Status last verified
- Oct 2020
- First submitted
- 21 Dec 2016
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REWARDS-In-stent Restenosis
- ClinicalTrials.gov ID
- NCT03008772
- Acronym / sponsor ID
- REWARDS-ISR
- Conditions
- In-Stent Coronary Artery Restenosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Feb 2018 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 2 Jan 2017 (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.
To define the long-term incidence and frequency of ISR follow DES implantation. Compare the clinical presentation, treatment and intervention success among de novo coronary artery stenosis and DES ISR.
Compare short- and long-term outcomes of de novo coronary artery stenosis and DES ISR, assessed by incidence of mortality, MACE, MI, and TLR/TVR at index hospitalization, 30 days, 6 months, 1 year, 3 years, and 5 years, if available.
Detailed description
Drug-eluting coronary stents (DES) significantly reduced the rate of neointimal hyperplasia and in-stent restenosis (ISR) compared to bare metal stents (BMS) for the treatment of coronary artery disease. In addition, the continued evolution in scaffold and polymer design with concomitant improvements in antiplatelet therapy has improved the rates of late and very late stent thrombosis. However, despite novel metal scaffold technology, increasing operator experience, and improvement in adjunctive implantation techniques, the incidence of ISR in durable-polymer DES remains a problem, with 1-year rates as high as 12 to 15%.
The outcomes associated with ISR highlight the fact that this is by no means a benign process and studies report MI rates as high as 19.4% with one study demonstrating a total rate of death or nonfatal MI of 3.5%. In addition, ISR presenting as acute coronary syndrome (ACS) has an independent effect on major adverse cardiac events. The emergence of fully bioresorbable vascular scaffolds (BVS) has provided an exciting alternative to combat the long-term structural and functional effects on the coronary vessel seen with implantation of a permanent metal scaffold, regardless of the drug coating. Initial studies have demonstrated the non-inferiority of BVS compared to contemporary DES in regards to death, MI, and MACE. In addition, intravascular imaging has confirmed complete resorbtion of the BVS by 3 years time. The long-term benefits of such technology have yet to be fully assessed. However, based on literature outlining the complicated course of ISR in short-term and that seen in the bare metal stent era, it is projected that complete resorbtion of the vascular scaffold should improve long-term outcomes of patients with ischemic heart disease.
Currently, the clinical presentation, incidence, and outcomes of ISR in contemporary DES are not completely understood. The goal of this particular study is to retrospectively evaluate the long-term impact of ISR over a 10-year period in current contemporary DES. The data can be compared to de novo coronary artery lesions with similar characteristics and complexity to highlight the significant differences in the clinical course of each disease. Ultimately, the investigators will hopefully demonstrate the need for improvement in this arena, which the BVS will potentially provide.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCI with Commercially available DES | – | –Patients who have undergone PCI and received a commercially available drug eluting stent |
| Stent Types | – | –the stent types for angina classification at follow up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All study subjects will be identified retrospectively. Patients who have undergone PCI and received a commercially available drug eluting stent as listed above. These patients will be compared between the stent types for angina classification at follow up.
Key inclusion criteria (2 listed)
- Patients, male or female, > 18 years of age,
- Patients who received at least one (1) commercially available Drug Eluting Stent
Key exclusion criteria (1 listed)
- none
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
Rate of Instent Restenosis
Time frame: Up to 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
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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?
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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 19 Oct 2020. 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 was withdrawn before enrolling participants, so there are no results.
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?
Rate of Instent Restenosis (time frame: Up to 5 years). 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 19 Oct 2020.