In-Stent Restenosis
Conditions
Keywords
Bare Metal In-Stent Restenosis, Paclitaxel Coated Balloon Catheter, Drug Coated Balloon, Coronary Artery Disease
Brief summary
The study will enroll patients with angiographic evidence of in-stent restenosis of a previously placed bare-metal stent. Subjects will be treated with a Lutonix Catheter. The purpose is to investigate the feasibility, safety, and efficacy of the Lutonix Catheter in the native coronary system. Angiographic and clinical outcomes will be assessed.
Interventions
PTCA
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or non-pregnant/non-breast feeding Female ≥18 Years of age. Women of childbearing potential must have a negative pregnancy test within 7 days of the procedure; * Documented stable angina pectoris Canadian Cardiovascular Society Classification (CCSC) 1-4, unstable angina pectoris with documented ischemia (Braunwald I-II) or documented silent ischemia; * Previous history of native coronary bare metal stenting ≥60 days; * LVEF ≥25%; * Patient is an acceptable candidate for PTCA, stenting, and emergent CABG; * Patient is willing to provide informed consent and comply with follow-up visits and testing schedule; * Target lesion is in a native coronary with previous single bare metal stent; Stenosis is ≥50% and \<100% by visual estimate or QCA prior to defined pre-dilatation; * Reference Vessel Diameter (RVD) is ≥2.5 and ≤3.25; * Target lesion is ≤40 mm in length and can be treated in its entirety by no more than 2 contiguous Lutonix Catheters; * Guidewire is able to cross lesion(s) and be placed in distal vessel prior to enrollment; * Enrollment permitted after successful treatment of 1 to 2 non-study lesions in a single other non-study vessel. Successful treatment is defined as ≤30% residual stenosis with TIMI III flow and no evidence of dissection.
Exclusion criteria
* History of Stroke within past 6 months; * History of MI or thrombolysis within 72 hours of randomization; * History of previous target vessel perforation; * Prior vascular brachytherapy; * Angiographic evidence of thrombus or dissection within the target vessel; * Intervention of another coronary lesion \<60 days before index procedure day or planned following index procedure; * Target lesion is in the Left Main or vessel ostium and has excessive calcification or tortuosity or involves bifurcation disease of vessel ≥2.5 mm; * Target lesion is planned to be treated with something other than PTCA (i.e. stent, cutting balloon, atherectomy, VBT, etc.); * Uncontrollable allergies to procedure medications, materials, or contrast; * Patient has previous stent procedure with any drug-coated or drug eluting stent device in the target coronary vessel; * Known sensitivity to paclitaxel or other antimitogenic agent; * Patient has a stent sandwich (a stench previously deployed within another stent; * Pre-procedure CKMB \>2x ULN or positive Troponin; * Creatinine \>2.0 mg/dl; * Leukocyte \<3500/mL; * Platelet \<100,000 mL or \>750,000 mL; * Currently taking or must resume warfarin; * Patient is contraindicated for anti-platelet therapy or it will need to be withdrawn for a planned procedure; * The patient is currently participating in another investigational drug or device study that has not completed its primary endpoint or that clinically interferes with the endpoints of this study;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Diameter Stenosis (%DS) in the Analysis Segment | 6 months | — |
| Change in Diameter Stenosis (%DS) From Post-procedure Through 6 Months | 6 Months | Paired change in percent diameter stenosis (%DS) in the analysis segment from post-procedure through 6 months. I.e., %DS at follow-up less %DS post procedure per patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late Lumen Loss | 6 months | Change in (loss of) lumen diameter from baseline through 6 months in the analysis segment (including the treated segment and 5mm proximal and distal). |
| MACE Rate | 30 Days | Major adverse coronary events (MACE), including the composite of cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR). |
| Binary Restenosis | 6 Months | Subjects with percent diameter stenosis \>50% in the analysis segment. |
Countries
Belgium, Germany, Netherlands
Participant flow
Recruitment details
Enrollment from June 3, 2009 through December 8, 2009 at 7 centers in Germany, Netherlands, and Belgium.
Participants by arm
| Arm | Count |
|---|---|
| Lutonix Catheter Lutonix Paclitaxel-Coated Balloon: PTCA | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Lutonix Catheter |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 27 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 64.4 Years STANDARD_DEVIATION 11 |
| Gender Female | 10 Participants |
| Gender Male | 31 Participants |
| Region of Enrollment Belgium | 1 participants |
| Region of Enrollment Germany | 36 participants |
| Region of Enrollment Netherlands | 4 participants |
| Target Lesion Location CFX | 17 participants |
| Target Lesion Location LAD | 13 participants |
| Target Lesion Location RCA | 11 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 41 |
| serious Total, serious adverse events | 22 / 41 |
Outcome results
Primary
Change in Diameter Stenosis (%DS) From Post-procedure Through 6 Months
Paired change in percent diameter stenosis (%DS) in the analysis segment from post-procedure through 6 months. I.e., %DS at follow-up less %DS post procedure per patient.
Time frame: 6 Months
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lutonix DCB Catheter | Change in Diameter Stenosis (%DS) From Post-procedure Through 6 Months | 8.5 percent diameter stenosis | Standard Deviation 16.9 |
Primary
Percent Diameter Stenosis (%DS) in the Analysis Segment
Time frame: 6 months
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lutonix DCB Catheter | Percent Diameter Stenosis (%DS) in the Analysis Segment | 36.0 Percentage stenosis of vessel diameter | Standard Deviation 17.6 |
Secondary
Binary Restenosis
Subjects with percent diameter stenosis \>50% in the analysis segment.
Time frame: 6 Months
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lutonix DCB Catheter | Binary Restenosis | 5 participants |
Secondary
Late Lumen Loss
Change in (loss of) lumen diameter from baseline through 6 months in the analysis segment (including the treated segment and 5mm proximal and distal).
Time frame: 6 months
Population: ITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lutonix DCB Catheter | Late Lumen Loss | 0.17 (mm) | Standard Deviation 0.39 |
Secondary
MACE Rate
Major adverse coronary events (MACE), including the composite of cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR).
Time frame: 30 Days
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lutonix DCB Catheter | MACE Rate | 0 Percentage of patients |