- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03667313
Treatment of In-Stent Restenosis 2 Study (TIS2)
Prospective Randomised Study Comparing Efficacy of Treatment Coronary In-stent Restenosis Using Sirolimus-Eluting and Iopromide-Coated Paclitaxel-Eluting Balloon Catheters
Study Overview
Status
Conditions
Detailed Description
Current therapy for in-stent restenosis (ISR) is based on the drug-eluting stents (DES) or drug-eluting balloon catheters (DEB). In clinical practice, paclitaxel is used as an effective antiproliferative agent loaded into DEB (paclitaxel-eluting balloon catheters; PEB).
In contrast to paclitaxel, sirolimus is difficult to deliver on the balloon surface, due to insufficient tissue uptake and shorter tissue retention of limus drugs. It was found that phospholipid-encapsulated sirolimus nanoparticles could be used for coating balloon catheters to provide efficient drug transfer to vessel wall with high tissue concentration.
This prospective randomized non-inferiority study compares the efficacy of new 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).
The primary end-point is in-segment late lumen loss (LLL) at 12 months as measured by quantitative coronary angiography (QCA).
Secondary end-points are the incidence of binary ISR (˃50% DS) and the overall incidence of 12-month major adverse cardiac events (MACE; cardiovascular death, non-fatal acute myocardial infarction [AIM], or target vessel revascularization [TVR]).
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Ostrava, Czechia, 70852
- Cardiovascular Department of University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: sirolimus-eluting balloon (SEB)
treatment of bare-metal (BMS) or drug-eluting in-stent restenosis (DES-ISR) with SEB
|
Patients with coronary in-stent restenosis treated with sirolimus-eluting balloon
Other Names:
|
Active Comparator: paclitaxel-eluting balloon (PEB)
treatment of BMS- or DES-ISR with PEB
|
Patients with coronary in-stent restenosis treated with paclitaxel-eluting balloon
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Late lumem loss (LLL)
Time Frame: 12-month
|
the diference between post-intervention mimimal lumen diameter (MLD) and 12-month MLD
|
12-month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
repeated binary restenosis
Time Frame: 12-month
|
recurrence of stenosis ≥50%
|
12-month
|
major adverse cardiac events (MACE)
Time Frame: 12-month
|
cardiovascular death, non-fatal acute myocardial infarction [AIM], or target vessel revascularization [TVR]
|
12-month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Coronary Disease
- Coronary Stenosis
- Coronary Restenosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Paclitaxel
- Sirolimus
Other Study ID Numbers
- FNO-TIS 2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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