Local Paclitaxel Delivery to Prevent Restenosis in Peripheral Arterial Disease

NCT03858764 | Withdrawn

• 1 other identifier: APMABR 7181
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Peripheral Arterial Disease; Restenosis

Keywords

Paclitaxel; Peripheral arterial disease; restenosis

Outcome Measures

Primary Outcomes (2)

• 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 Safety

  Freedom from death, major amputation in the target limb, or Target Lesion Revascularization (either surgical or endovascular)

  1 month

Secondary Outcomes (5)

• Primary Patency

  1, 3, and 12 months

• Primary Assisted Patency

  6, 12 months

• Secondary Patency

  6, 12 months

• Functional Status

  1, 3, 6, and 12 months

• Secondary Safety

  1, 3, 6, 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with peripheral arterial disease and subsequent restenosis of the previously treated femoropopliteal region seen in either the Bluestem Cardiology Office or at Jane Phillips Medical Center under the care of one of the Bluestem cardiologists

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jane Phillips Medical Center: lead

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Cardiologist

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 1, 2019
• Study Start: August 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 4, 2019

Record last verified: 2019-02