An Exploratory Study Investigating the Use of the Lutonix Paclitaxel-Coated Balloon in Conjunction with Bare Metal Stenting in Patients with De Novo Coronary Lesions

An Exploratory Study Investigating the Use of the Lutonix Paclitaxel-Coated Balloon in Conjunction with Bare Metal Stenting in Patients with De Novo Coronary Lesions - The Lutonix De Novo Pilot Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33221

Enrollment

Registered

2009-06-23

Start date

2009-07-24

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary artery disease

Interventions

The intervention is the same as usual with exception of the OCT. This is not part of the standard procedure but is performed on regular basis during a PCI procedure.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Documented stable angina pectoris CCSC 1-4, unstable angina pectoris with documented ischemia (Braunwald 1-II) or documented silent ischemia Target lesion is a de novo lesion in a native coronary artery vessel Initial stenosis is >50% and

Exclusion criteria

Exclusion criteria: History of Stroke within past 6 months History of MI or thrombolysis within 72 hours of randomization Prior vascular brachytherapy Angiographic evidece of thrombus or dissection within the target vessel

Design outcomes

Primary

Measure	Time frame
Mean percent stent volume obstruction at 6 months.	—

Secondary

Measure	Time frame
OCT endpoints (Quantitative assessment): Post Procedure: Stent Malapposition; Minimal Lumen Area (MLA) [mm2]; Stent Symmetry; Stent Expansion At follow-up: Stent Malapposition; MLA [mm2]; Stent strut coverage OCT endpoints (Qualitative assessment): Post procedure: Tissue Prolapse; Residual edge dissection; Thrombus; Angiographic endpoints: Minimal Lumen Diameter (MLD); Late Luminal Loss (LLL); percent Diameter Stenosis (%DS); and Restenosis Rate (RR) at follow-up of the analysis segment as assessed by off-line Quantitative Coronary Analysis (QCA); All measuremenst will be made of the in-stent and the analysis segment Safety and Clinical endpoints: Combined and individual endpoints including all cause death, cardiac death, myocardial infarction, clinically indicated Target Lesion Revascularization (TLR) and Target Vessel Revascularization (TVR); overall TLR and TVR Safety endpoints, including: Stent thrombosis according tot the Academy Research Consortium (ARC) definitions; Major and minor bleedings; other serious adverse events	—

Measure

Time frame

OCT endpoints (Quantitative assessment): Post Procedure: Stent Malapposition; Minimal Lumen Area (MLA) [mm2]; Stent Symmetry; Stent Expansion At follow-up: Stent Malapposition; MLA [mm2]; Stent strut coverage OCT endpoints (Qualitative assessment): Post procedure: Tissue Prolapse; Residual edge dissection; Thrombus; Angiographic endpoints: Minimal Lumen Diameter (MLD); Late Luminal Loss (LLL); percent Diameter Stenosis (%DS); and Restenosis Rate (RR) at follow-up of the analysis segment as assessed by off-line Quantitative Coronary Analysis (QCA); All measuremenst will be made of the in-stent and the analysis segment Safety and Clinical endpoints: Combined and individual endpoints including all cause death, cardiac death, myocardial infarction, clinically indicated Target Lesion Revascularization (TLR) and Target Vessel Revascularization (TVR); overall TLR and TVR Safety endpoints, including: Stent thrombosis according tot the Academy Research Consortium (ARC) definitions; Major and minor bleedings; other serious adverse events

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)