Status:
COMPLETED
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
Lead Sponsor:
Tryton Medical, Inc.
Conditions:
Coronary Atherosclerosis of Native Coronary Artery
Bifurcation Lesions: de Novo Lesions of the Main and Side Branch of Native Coronary Artery
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
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 performanc...
Detailed Description
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....
Eligibility Criteria
Inclusion
- 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.
- General 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.
Exclusion
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
133 Patients enrolled
Trial Details
Trial ID
NCT01258972
Start Date
December 1 2010
End Date
October 1 2016
Last Update
October 18 2016
Active Locations (1)
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1
Jeffery Moses
New York, New York, United States, 10032