Coronary Restenosis Clinical Trial
— TIS2Official title:
Prospective Randomised Study Comparing Efficacy of Treatment Coronary In-stent Restenosis Using Sirolimus-Eluting and Iopromide-Coated Paclitaxel-Eluting Balloon Catheters
Verified date | December 2022 |
Source | University Hospital Ostrava |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to compare the efficacy of sirolimus-eluting balloon catheters (SEB) and iopromide-coated paclutaxel-eluting balloon catheters (PEB) in the treatment of bare metal (BMS) - or drug-eluting stents restenosis (DES-ISR).
Status | Completed |
Enrollment | 200 |
Est. completion date | December 31, 2021 |
Est. primary completion date | November 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - patients with BMS- or DES-ISR (?50% diameter stenosis; DS) - =18 years of age - willing to sign an Informed consent Exclusion Criteria: - concomitant diseases with an expected survival time of less than 12 months - or that limited the possibility of control coronary aniography (e.g., advanced renal failure). - impossibility of long-term (6 months) dual antiplatelet treatment |
Country | Name | City | State |
---|---|---|---|
Czechia | Cardiovascular Department of University Hospital | Ostrava |
Lead Sponsor | Collaborator |
---|---|
University Hospital Ostrava |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Late lumem loss (LLL) | the diference between post-intervention mimimal lumen diameter (MLD) and 12-month MLD | 12-month | |
Secondary | repeated binary restenosis | recurrence of stenosis =50% | 12-month | |
Secondary | major adverse cardiac events (MACE) | cardiovascular death, non-fatal acute myocardial infarction [AIM], or target vessel revascularization [TVR] | 12-month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01205776 -
EXCEL Clinical Trial
|
N/A | |
Active, not recruiting |
NCT04475380 -
Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
|
||
Completed |
NCT02263313 -
EGO-COMBO Clinical End-point Extension Study Beyond 36 Months
|
N/A | |
Completed |
NCT00248066 -
Safety and Efficacy of RESTEN-MP When Used in Conjunction With a Bare Metal Stent in Coronary Arteries
|
Phase 2 | |
Completed |
NCT00148356 -
Safety and Efficacy of the ZoMaxx™ Drug-Eluting Stent System in Coronary Arteries
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT02508714 -
Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents
|
N/A | |
Completed |
NCT01205789 -
EXCEL Clinical Trial (Universal Registry)
|
N/A | |
Completed |
NCT01274234 -
OCT Evaluation of Healing of COMBO Stent
|
Phase 1/Phase 2 | |
Recruiting |
NCT00426049 -
Systemic Treatment With Everolimus for the Prevention of MACE After Bare Metal Stent Implantation
|
Phase 3 | |
Terminated |
NCT00243308 -
Serp-1 for the Treatment of Acute Coronary Syndrome
|
Phase 2 | |
Completed |
NCT00180466 -
PROSPECT: An Imaging Study in Patients With Unstable Atherosclerotic Lesions
|
N/A | |
Completed |
NCT00859183 -
Oral Sirolimus for In-Stent Restenosis
|
Phase 4 | |
Recruiting |
NCT05089864 -
STAR and Deferred Stenting Study
|
N/A | |
Active, not recruiting |
NCT02175706 -
DUrable Polymer-based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity
|
N/A | |
Completed |
NCT01331707 -
DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity in an All Comers Population
|
Phase 4 | |
Completed |
NCT01249027 -
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval, Single-Arm Study
|
||
Recruiting |
NCT00500279 -
Effects of Celecoxib On Restenosis After Coronary Intervention and Evolution of Atherosclerosis Trial
|
Phase 4 | |
Completed |
NCT00402272 -
SPIRIT V: Post-marketing Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in Europe
|
Phase 4 | |
Completed |
NCT01171820 -
SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study)
|
Phase 4 | |
Recruiting |
NCT06075602 -
COMPLEX Registry - A Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting With compLEX and Calcified Coronary Artery Disease
|