The primary objective of this registry trial is to assess the safety and effectiveness of the Tryton sidebranch stent in de novo native coronary bifurcated lesions.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Composite Endpoint- *Procedural Success*
- Successful deployment of the Tryton sidebranch
- Angiographic Success: <30% residual stenosis in main vessel and sidebranch
and TIMI 3 flow post-procedure
- Without in-hospital Major Adverse Cardiac Event (MACE)
Secondary outcome
Clinical Parameters:
- Non-MACE, Serious Adverse Events (SAE) at hospital discharge
- MACE and Anginal Status at post procedure and up to nine (9) months
Angiographic Parameters
- Acute IVUS Success
- Angiographic restenosis at six months
- Volumetric Late Loss by IVUS at six months
- In-stent and vessel segment percentage DS (diameter stenosis) post-procedure
Background summary
Bifurcation lesions, i.e., lesions involving a significant side branch diameter
>= 2.2 mm occur in approximately 15% of all coronary lesions considered for
percutaneous intervention. Since a side branch (SB) of this diameter provides
blood supply to a significant myocardial territory, failure to preserve SB
vessel patency has been associated with significant complications Early
interventional experience using balloon angioplasty (PTCA) for the treatment of
bifurcation lesions were associated with higher rates of acute complications in
the side branch, restenosis and target vessel revascularization due to
complications with the SB The data that is available for DES placements in a SB
suggest that the results for SB stenting were not as favorable. This study and
others suggest that the outcomes are related to the way the stents sit within
the vessel and fit together in the difficult bifurcation anatomy.
Therefore a stent designed specifically for bifurcation lesions will be needed
to reduce restenosis rates and improve long term outcomes.
Study objective
The primary objective of this registry trial is to assess the safety and
effectiveness of the Tryton sidebranch stent in de novo native coronary
bifurcated lesions.
Study design
This is multi-center, prospective, non-randomized single arm study. This study
will involve the collection of demographic, clinical, and angiographic data on
the targeted patient population. Patients will be followed up clinically for 9
months post -procedure and receive a control angiography at 6 months
post-procedure. Approximately 30, patients from maximum 3 centers will be
included in the study.
Intervention
The Tryton sidebranch stent is developed to treat bifurcation lesions. The
Tryton stent itself will be placed in the sidebranch. The Cypher stent will be
placed in the main vessel.
Study burden and risks
The possible risks are not different from other stent implants as mentioned in
the brochure of the Nederlandse Hartstichting
- Death 0.2%-0.5%
- MI during the intervention
- Haematoma at the access site
- Major bleedings due to anti coagulance medication given during or after the
procedure
The possible risks related to the medication
The standard medication that you will receive (aspirin and clopidogrel,or
ticlopidine) is meant to minimize the likelihood of clot formation at the stent
site. This medication is standard for patients who receive a stent.
- Aspirin mincrease the likelihood of gastrointestinal adverse effects and
bleeding.
- A recent study with Clopidogrel showed that this medication shows less
adverse events tnen Asperin
- Clopidogrel is uncommonly associated with rash, diarrhea, nausea, vomiting,
stomach pain, and blood disorder
2330 Washington Street
Newton, MA 02462
USA
2330 Washington Street
Newton, MA 02462
USA
Listed location countries
Age
Inclusion criteria
Patients from 18- 85 years of age.
Patients with symptomatic ischemic heart disease and/or objective evidence of myocardial ischemia.
Treatment of a single de novo lesion involving a side branch.
Main vessel target lesion is located in a native coronary artery.
Exclusion criteria
Totally occluded vessel
Excessive tortuousity
Evidence of thrombus
A significant > 50% stenosis proximal or distal to the target lesion.
Females who are pregnant or nursing or females of childbearing potential
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL13681.078.06 |