Prospective, Single Blind, Rand Controlled Study to Evaluate the Safety & Effectness of Tryton Side Branch Stent Used With DES Treatmt of de Novo Bifurcation Lesions in MB & SB in Native Coronaries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The Tryton Side Branch Stent System has been designed to address the procedural difficulty surrounding treatment of bifurcation lesions and to ensure patency of the side branch with similar performance capabilities (e.g., tracking, radiopacity, coverage and radial strength) that are currently available with conventional coronary stents designed for straight (non bifurcation) lesions.

The Tryton Side Branch Stent is intended to treat and maintain patency in the side branch/carina by providing better ostial side branch conformability and is intended for use in conjunction with currently approved balloon-expandable drug-eluding stents for treatment of the main branch.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

eTryton Left Main Registry Tryton Side Branch Stent® Tmt of Denovo CAD in LM and CFX Arteries

NCT02765646

Left Main Coronary Artery Stenosis

UNKNOWN

Bifurcation Stenting Using 2 Link Stent Nobori Versus 3 Link Stent Xience

NCT01574586

Coronary Stenosis

UNKNOWN NA

Bare Metal Bifurcation Stent Clinical Trial in Humans

NCT00607321

Coronary Artery Disease Myocardial Ischemia

COMPLETED NA

To Evaluate Safety and Efficacy of CGBIO Stent Compared to Biomatrix Flex Stent

NCT03089450

Ischemic Heart Disease Stable Coronary Artery Disease Stable Angina +2 more

UNKNOWN NA

Smart Angioplasty Research Team-Optimal Strategy for Side Branch Stenting in Coronary Bifurcation Lesion With Drug-Coated Balloon

NCT07019350

Coronary Artery Disease

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The use of drug-eluding stents in the treatment of bifurcation lesions suggests that DES reduces the rate of restenosis int he main branch (5-10%); however, results int he side branch are not optimal. A study of T stenting in true bifurcation lesions showed a restenosis rate int he main branch of approximately 6% using the CYPHER stent. However, the same study demonstrated that the restenosis rate remained high int he side branch (20%) despite stent implantation and when restenosis occurs, it is generally located at the ostium of the side branch. Further, in half the cases where PTCA alone was the intended strategy for the side branch, a side branch stent had to be placed to address sub-optimal procedural results.

These findings are consistent with previous metal stent studies and suggest the best long-term results are obtained when a side branch stent is not placed. This study and others suggest that the outcomes are related to the way the stents sit within in the vessel; and therefore a stent designed specifically for bifurcation lesions will be needed to reduce restenosis rates and improve long-term outcomes.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Atherosclerosis of Native Coronary Artery Bifurcation Lesions: de Novo Lesions of the Main and Side Branch of Native Coronary Artery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Angioplasty POBA

Side Branch balloon angioplasty with main branch DES

Group Type ACTIVE_COMPARATOR

POBA

Intervention Type DEVICE

Balloon angioplasty

Tryton Side Branch Stent

Side Branch treated with Tryton Side Branch Stent with main branch DES

Group Type EXPERIMENTAL

Tryton Side Branch Stent with main branch DES

Intervention Type DEVICE

Tryton Side Branch Stent

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tryton Side Branch Stent with main branch DES

Tryton Side Branch Stent

Intervention Type DEVICE

POBA

Balloon angioplasty

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* The patient must be ≥18 and ≤ 90 years of age;
* Symptomatic ischemic heart disease (CCS class 1-4, Braunwald Class IB, IC, IIB, IIC, IIIB, IIIC, and/or have objective evidence of myocardial ischemia);
* Acceptable candidate for CABG;
* Intent to treat the side branch of the target bifurcation based on angiographic evaluation;
* The patient is willing to comply with specified follow-up evaluations;
* The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written informed consent, approved by the appropriate Medical Ethics Committee (MEC) or Institutional Review Board (IRB).
* Planned use of one of the following approved and commercially available drug-eluting stents for subject's index procedure: CYPHER®, ENDEAVOR® RESOLUTE, PROMUS® or PROMUS® ELEMENT, XIENCE™ V or XIENCE PRIME.

Exclusion Criteria

* Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test;
* Patient has had a known diagnosis of STEMI acute myocardial infarction (AMI) within 72 hours preceding the index procedure or \>72 hours preceding the index procedure and CK and CK-MB have not returned to within normal limits at the time of procedure;
* Patients with non-STEMI within 7 days prior to index procedure with continued CK-MB elevation;
* Patients with non-target lesion PCI within 7 days prior to index procedure with continued CK-MB elevation;
* Impaired renal function (serum creatinine \>2.5 mg/dL or 221 μmol/l) or on dialysis;
* Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3 or a WBC \<3,000 cells/mm3;
* Patient has a history of bleeding diathesis or coagulopathy or patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or any other significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study;
* Patient has received an organ transplant or is on a waiting list for any organ transplant;
* Patient has other medical illness (e.g., cancer, known malignancy, or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year);
* Patient has a known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, clopidogrel/ticlopidine, prasugrel, stainless steel alloy, cobalt-chromium alloy, rapamycin, everolimus, zotarolimus, paclitaxel, and/or contrast sensitivity that cannot be adequately pre-medicated;
* Patient presents with cardiogenic shock or cardiac arrhythmias that create hemodynamic instability;
* Patient in whom a surgical or other procedure is planned within the next year which would require discontinuation of dual antiplatelet therapy;
* Currently participating in another investigational drug or device study or patient inclusion in another investigational drug or device study where the primary endpoint of the study has not been reached.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes