Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT01904851 |
| Other study ID # |
STU 052012-093 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2013 |
| Est. completion date |
January 2033 |
Study information
| Verified date |
December 2023 |
| Source |
Baylor Research Institute |
| Contact |
David Fernandez Vazquez, MD |
| Phone |
2148202928 |
| Email |
david.fernandezvazquez[@]bswhealth.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
XLPAD is an observational study designed to evaluate the effectiveness and use of stent and
non-stent based therapies among PAD patients. The study will create a registry that will
include entry of procedural and clinical follow-up information into an online data collection
software, REDCAP.Data available since Jan 1 2005 will be included in the registry, until
14,000 patients have been included. The primary objectives of this observational registry
study are to:
1. Compare stent and non-stent based outcomes defined as a composite of symptom driven
target vessel revascularization (TVR), unplanned surgical revascularization of the
target limb and need for target limb amputation through 12 months post-index procedure
(Primary efficacy endpoint)
2. Compare stent and non-stent based outcomes defined as a composite of causes such as:
death, myocardial infarction (MI), stroke, peri-procedural complications, target vessel
revascularization (TVR) and unplanned surgical revascularization/amputation of the
target limb through 12 months (Primary safety endpoint)
3. Compare stent and non-stent based change in walking distance, Rutherford category and/or
ankle- brachial index (ABI) at 12 months compared to baseline (Primary clinical
improvement endpoint)
Approximately 14,000patients will be enrolled at approximately 60 sites worldwide. Enrollment
in the observational study will be monitored in an effort to achieve at least 20% (and no
more than 80%) of the population receiving stents as the initial treatment strategy.
Follow-up visits by sites will be reported at 6 and 12 months after index procedure to
collect data on treatment patterns and effectiveness, and outcomes. The follow-up procedures
are not mandated by the registry protocol. Each site will be encouraged to enter follow-up
information derived from clinically indicated follow-up visits. All events post-index
procedure till the 7th month will be reported under the 6 month follow-up form and subsequent
follow-up till the 13th month post-procedure will be entered on the 12 month follow-up form.
Patient management and treatment decisions are at the discretion of the care team per routine
clinical practice. The procedural aspects (including selection of stent type or non-stent
based treatments) and follow-up are not mandated by the registry and will be up to the
discretion of the operator and/or based upon the practice dictated by the clinical care of
the patient. Therefore the study poses minimal risk to the patient.
Description:
Patients undergoing an endovascular intervention receiving either stents or percutaneous
transluminal angioplasty (PTA) to the superficial femoral, popliteal, peroneal, anterior
tibial, or posterior tibial arteries will be entered into this registry. Patients undergoing
treatment of the external or common iliac arteries are not admissible to the registry, unless
these arteries were treated in addition to one of the five aforementioned arteries. The
registry will collect data in the form of patient background information, procedural data,
and follow-up data from the patient's medical records. Data available since Jan 1 2005 will
be included in the registry, until 14,000 patients have been included. The data will be
entered into a software, REDCAP, that automatically provides data quality verification and
processing.
Specifically, the data fields collected by the registry will be:
I) Background Information
1. Site, attending operator, and month-year of procedure
2. Patient height, weight, age, race, and sex
3. Rutherford claudication category, left and right ankle brachial index, ambulatory
status, claudication free distance
4. Risk factors such as diabetes, hypertension, hyperlipidemia, and prior history of lower
extremity percutaneous intervention
5. Patient comorbidities such as coronary artery disease, congestive heart failure, prior
myocardial infarction, stroke, transient ischemic attack, chronic kidney disease, and
other.
II) Lesion Characteristics (enter data for up to five lesions)
1. Access site relative to target limb, sheath size, target limb (left or right)
2. Target vessel: superficial femoral artery, popliteal artery, peroneal artery, anterior
tibial artery, or posterior tibial artery
3. Which, if any, Iliac arteries were treated during procedure
4. Target lesion location (ostial, proximal, medial, distal), estimated vessel diameter,
estimated vessel length
5. Lesion characteristics (heavily calcified, diffuse, thrombus, chronic total occlusion
(CTO), in-stent restenosis, restenosis post balloon angioplasty, profunda femoris
disease)
6. Planned revascularization strategy: stent or non-stent based
IIa) CTO Characteristics (Only required for CTO lesions)
1. Type of proximal and distal stumps, sidebranches present, collateral filling of distal
vessel, tortuosity, prior attempt to cross CTO
2. Antegrade or retrograde crossing strategy, crossing technique, number of attempts
3. Crossing devices used, microcatheters used, sub-intimal re-entry devices used (if any),
embolic protection device used
III) Intervention Details
1. Atherectomy device used (Cutting Balloon, TurboHawk, SilverHawk, Rotablator, Laser)
2. Pre and post-dilation balloon information (type, length, width, average atmospheric
pressure, number of inflations)
3. Stent information (indication for stents, length, width, maximum pressure, overlapping
with previous stents)
4. Aspiration/Thrombectomy used, thrombolytic therapy used
5. Percent change in stenosis and TIMI flows (before and after)
IV) Outcomes
1. Technical success (<30% residual stenosis), procedural success (<30% residual stenosis
without complications), and case comments
2. Anti-coagulation used, medical therapy (plavix, aspirin, lipid lowering therapy,
angiotensin receptor blocker, beta blocker, cilostazol, trental, insulin, oral
hypoglycemics)
3. Duration of procedure, fluoroscopy (amount used, type, and time)
4. Any procedural complications
V) Follow-Up
1. Month and year of follow-up
2. Rutherford category, left and right ankle brachial index, claudication-free distance,
ambulatory status, change in claudication (improved, same, or worsened)
3. Duplex ultrasound performed
4. Adverse events experienced (death, myocardial infarction, stroke, stent thrombosis,
stent fracture, angiography, repeat endovascular intervention, surgical
revascularization, amputation in target or non-target limb)
Follow-up data is recorded from clinical visits six and twelve months after the procedure. If
the patient undergoes a repeat intervention on the target limb, a new record is created for
the procedure.
