Peripheral Arterial Disease Clinical Trial
— ResTAPOfficial title:
Local Paclitaxel Delivery to Prevent Restenosis Using the TAPAS Catheter After Endovascular Revascularization in Patients With Previous Femoropopliteal Intervention
NCT number | NCT03858764 |
Other study ID # | APMABR 7181 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | August 2013 |
Est. completion date | August 2013 |
Verified date | February 2019 |
Source | Jane Phillips Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to determine if the addition of a catheter-based local delivery of paclitaxel into the peripheral arterial vessels in patients with peripheral arterial disease (PAD) and subsequent restenosis of the femoropopliteal region would benefit from this type of investigational intervention with a known antiproliferative agent.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 2013 |
Est. primary completion date | August 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 years of age or older - Rutherford Stages 2-5 plus prior history of endovascular revascularization and recurrent stenosis (in stent, post angioplasty, post atherectomy) (Table 1 ) - one or more restenotic lesions within the SFA of at least 70% of the vessel diameter - Successful percutaneous revascularization of the femoropopliteal artery (< 20% residual stenosis by visual estimate) using standard techniques per discretion of the local operator - The femoropopliteal Reference Vessel Diameter (RVD) must be =4.0 mm and =7.0 mm Exclusion Criteria: - Patient is pregnant or breast feeding. (Female subjects of childbearing potential must have negative serum pregnancy test the day of the procedure.) - Life expectancy < 12 months. - Contraindication to aspirin, clopidogrel or other thienopyridine, heparin, low molecular weight heparin, bivalirudin or other therapies required for procedure or follow up. - Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure. - Known allergy to paclitaxel. - Uncontrolled hypercoagulability or history of HIT or HITTS syndrome. - Simultaneous enrollment in another investigational device or drug study. - Absence of at least 1 TIMI-3 vessel run off into the foot. - Platelet count < 100,000/mm3. - White blood cell count < 1.5/mm3. - Any evidence of perforation or dye extravasation during the index procedure, even if successfully treated with a covered stent. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Jane Phillips Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Patency | Loss of primary patency will occur for any clinically driven Target Lesion Revascularization (TLR) as determined by Rutherford scale on claudication and a Peak Systolic Velocity Ratio (PSVR) of > 2.5 on Duplex Ultrasound (DUS), or CTA quantified stenosis = 70% | 6 months | |
Primary | Primary Safety | Freedom from death, major amputation in the target limb, or Target Lesion Revascularization (either surgical or endovascular) | 1 month | |
Secondary | Primary Patency | Loss of primary patency will occur for any clinically driven Target Lesion Revascularization (TLR) or a Peak Systolic Velocity Ratio (PSVR) of > 2.5 on Duplex Ultrasound (DUS), CTA quantified stenosis = 70% | 1, 3, and 12 months | |
Secondary | Primary Assisted Patency | Patency of the target vessel regardless of secondary interventions performed to restore blood flow after restenosis. | 6, 12 months | |
Secondary | Secondary Patency | Patency of the target vessel regardless of secondary interventions performed to restore blood flow after re-occlusion | 6, 12 months | |
Secondary | Functional Status | Rutherford Classification | 1, 3, 6, and 12 months | |
Secondary | Secondary Safety | adverse events associated with the use of paclitaxel, such as, but not limited to: hypotension, anaphylactic reactions, nausea, vomiting, diarrhea pancytopenia, neuropathy, alopecia which will be determined by clinical assessment and review of systems at time of exam | 1, 3, 6, 12 months |
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