- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03008772
REWARDS- In-stent Restenosis
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.
Study Overview
Status
Conditions
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 Type
Contacts and Locations
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
- MedStar Washington Hospital Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients, male or female, > 18 years of age,
- Patients who received at least one (1) commercially available Drug Eluting Stent
Exclusion Criteria:
none
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of Instent Restenosis
Time Frame: Up to 5 years
|
Up to 5 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REWARDS-ISR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on In-Stent Coronary Artery Restenosis
-
Shanghai MicroPort Medical (Group) Co., Ltd.Not yet recruitingCoronary Artery In-stent Restenosis
-
B. Braun Medical Inc.Infraredx; Bright Research PartnersWithdrawnCoronary Artery Restenosis | In-stent Restenosis | In-stent Coronary Artery Restenosis
-
Second Affiliated Hospital, School of Medicine,...West China Hospital; The Third Xiangya Hospital of Central South University; Shanghai... and other collaboratorsUnknownCoronary In-stent RestenosisChina
-
Spanish Society of CardiologyAbbott Medical Devices; Terumo Medical Corporation; Fundación de Investigación... and other collaboratorsUnknownCoronary In-stent RestenosisSpain
-
Rambam Health Care CampusCompletedIn-stent Coronary Artery RestenosisIsrael
-
Medstar Health Research InstituteUnknownIn-stent Coronary Artery RestenosisUnited States
-
Biotronik AGCompletedIn-stent Coronary Artery RestenosisGermany
-
DK Medical Technology (Suzhou) Co., Ltd.Core Medical (Beijing) Co., Ltd.Active, not recruitingCoronary In-stent RestenosisChina
-
Ospedale Santa Maria GorettiWithdrawnIn-stent Coronary Artery RestenosisItaly
-
MINVASYSEuropean Cardiovascular Research CenterCompletedIn-stent Coronary Artery RestenosisFrance