A Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Tryton Side Branch Stent* used in Conjunction with a Drug-Eluting Stent Compared to Side Branch Balloon Angioplasty in Conjunction with a Drug-Eluting Stent in the Treatment of de novo Bifurcation Lesions Involving the Main Branch and Side Branch within the Native Coronary Circulatio

Recruiting

• Conditions: Treatment of de novo Bifurcation Lesions Involving the Main Branch and Side Branch within the Native Coronary Circulation; 10011082

• Registration Number: NL-OMON37935
• Lead Sponsor: Tryton Medical Corporate Headquarters

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2016-11-21
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 105

Inclusion Criteria

Patients must meet ALL of the following criteria:
General Inclusion Criteria
1. The patient must be >=18 and <= 90 years of age;
2. Symptomatic ischemic heart disease (CCS class 1-4, Braunwald Class IB, IC, IIB, IIC, IIIB, IIIC, and/or have objective evidence of myocardial ischemia);
3. Acceptable candidate for CABG;
4. The intent to treat the side branch of the target bifurcation based on angiographic evaluation;
5. The patient is willing to comply with specified follow-up evaluations;
6. 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).
7. Planned use of one of the following approved and commercially available drug-eluting stents for subject*s index procedure: CYPHER®, RESOLUTE Family of products (ENDEAVOR®
RESOLUTE or RESOLUTE INTEGRITY), PROMUS®, PROMUS ELEMENT Family of products (PROMUS® ELEMENT or PROMUS ELEMENT PLUS), XIENCE* V, or the XIENCE
PRIME Family of products (XIENCE PRIME, XIENCE Xpedition or XIENCE PRO)

Angiographic Inclusion Criteria
8. a)Single de novo lesion in a bifurcation involving both the main branch and the side branch with
b) The bifurcation: main branch and side branch with a visual diameter stenosis >= 50% (Medina classification 1.1.1; 0.1.1; 1.0.1 by visual assessment);
9. Target lesion located in a native coronary artery;
10. a)Bifurcation lesion main branch reference vessel diameter must be >=2.5 mm to <= 4.0 mm
b) Side branch reference vessel diameter must be >=2.5 mm to <= 3.5 mm by visual estimate;
11. a) Bifurcation lesion main branch lesion length <= 28 mm
b) Side branch lesion length <= 5.0 mm (the ability to be treated with a single stent for both main and side branch);
12. Target lesion >=50% and <100% stenosed by visual estimate in both the main branch and side branch;
Refer to Protocol 1.9.5 for full list of Inclusion Criteria

Exclusion Criteria

Patients will be excluded if ANY of the following conditions apply:
General Exclusion Criteria
1. 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;
2. 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;
3. Patients with non-STEMI within 7 days prior to index procedure with continued CK-MB elevation;
4. Patients with non-target lesion PCI within 7 days prior to index procedure with continued CK-MB elevation;
Angiographic Exclusion Criteria
5. Left main coronary artery disease (protected and unprotected)
6. Trifurcation lesion;
7. Totally occluded target vessel (TIMI flow 0 or 1);
8. Severely calcified target lesion(s);
9. Highly calcified target lesion(s) requiring rotational atherectomy;
10. Target lesion has excessive tortuosity unsuitable for stent delivery and deployment;
11. Angiographic evidence of thrombus in the target lesion(s);
Refer to Protocol for full list of Exclusion Criteria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint:<br /><br>Target Vessel Failure (TVF) defined as the composite of cardiac death, target<br /><br>vessel myocardial infarction (Q wave or non-Q wave) and target vessel<br /><br>revascularization (main branch or side branch) of the Tryton Side Branch Stent*<br /><br>with main branch DES compared to side branch balloon angioplasty and main<br /><br>branch DES at 9 months.</p><br>