Local Delivery of Paclitaxel Via the TAPAS Catheter to Prevent Restenosis From Percutaneous Femoropopliteal Intervention

NCT01599078 | Unknown DMC

• 1 other identifier: MCRF-001-EJD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety and efficacy of administering intra-arterial paclitaxel in the femoropopliteal arteries via the TAPAS catheter following percutaneous revascularization to prevent restenosis.

Conditions

Restenosis; Peripheral Arterial Disease

Keywords

Restenosis; Angioplasty; Stent; Atherectomy; Femoral Artery; Popliteal Artery; Paclitaxel

Outcome Measures

Primary Outcomes (2)

• 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)

  6 months

• Primary Safety

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

  30 days

Secondary Outcomes (5)

• Primary Patency at 12 months

  12 months

• Primary Assisted Patency

  6 and 12 months

• Secondary Patency

  6 and 12 months

• Functional Status

  30 days, 6 months, and 12 months

• Secondary Safety

  30 days, 6 months, and 12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Paclitaxel

ACTIVE COMPARATOR

Drug: Paclitaxel

Interventions

Paclitaxel DRUG

Drug dosing is 3mcg/mm3 of artery treated with percutaneous revascularization. Drug will be administered via the TAPAS catheter and allowed to dwell for 5 minutes.

Also known as: Taxol

Paclitaxel

Placebo DRUG

Saline will be administered intra-arterially via the TAPAS catheter following percutaneous revascularization. The dwell time will be 5minutes.

Placebo

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old.
• Subject able to provide informed consent and agree to all follow up requirements.
• Peripheral arterial disease with Rutherford Class 2-5.
• 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, anti-platelet/anti-coagulant therapies required for procedure/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.
• Previous intervention of the target limb with a drug eluting stent or drug eluting balloon.
• Absence of at least 1 TIMI-3 vessel run off into the foot.
• Total bilirubin \> 2x upper limit of normal (ULN).
• ALT or AST \> 3x ULN.
• 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

• Midwest Cardiovascular Research Foundation: lead
• Spectranetics Corporation: collaborator

Study Sites (1)

Trinity Medical Center

Bettendorf, Iowa, 52722, United States

RECRUITING

Related Publications (8)

• Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008 Feb 14;358(7):689-99. doi: 10.1056/NEJMoa0706356.

  PMID: 18272892 BACKGROUND

• Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008 Sep 23;118(13):1358-65. doi: 10.1161/CIRCULATIONAHA.107.735985. Epub 2008 Sep 8.

  PMID: 18779447 BACKGROUND

• Hawkins BM, Hennebry TA. Local paclitaxel delivery for treatment of peripheral arterial disease. Circ Cardiovasc Interv. 2011 Jun;4(3):297-302. doi: 10.1161/CIRCINTERVENTIONS.110.961052. Epub 2011 May 3. No abstract available.

  PMID: 21540442 BACKGROUND

• Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Zeller T, Roubin GS, Burket MW, Khatib Y, Snyder SA, Ragheb AO, White JK, Machan LS; Zilver PTX Investigators. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011 Oct 1;4(5):495-504. doi: 10.1161/CIRCINTERVENTIONS.111.962324. Epub 2011 Sep 27.

  PMID: 21953370 BACKGROUND

• Speck U, Scheller B, Abramjuk C, Grossmann S, Mahnkopf D, Simon O. Inhibition of restenosis in stented porcine coronary arteries: uptake of Paclitaxel from angiographic contrast media. Invest Radiol. 2004 Mar;39(3):182-6. doi: 10.1097/01.rli.0000116125.96544.64.

  PMID: 15076010 BACKGROUND

• Scheller B, Speck U, Schmitt A, Bohm M, Nickenig G. Addition of paclitaxel to contrast media prevents restenosis after coronary stent implantation. J Am Coll Cardiol. 2003 Oct 15;42(8):1415-20. doi: 10.1016/s0735-1097(03)01056-8.

  PMID: 14563585 BACKGROUND

• Herdeg C, Gohring-Frischholz K, Haase KK, Geisler T, Zurn C, Hartmann U, Wohrle J, Nusser T, Dippon J, May AE, Gawaz M. Catheter-based delivery of fluid paclitaxel for prevention of restenosis in native coronary artery lesions after stent implantation. Circ Cardiovasc Interv. 2009 Aug;2(4):294-301. doi: 10.1161/CIRCINTERVENTIONS.108.827865.108.827865. Epub 2009 Jul 22.

  PMID: 20031731 BACKGROUND

• Margolis J, McDonald J, Heuser R, Klinke P, Waksman R, Virmani R, Desai N, Hilton D. Systemic nanoparticle paclitaxel (nab-paclitaxel) for in-stent restenosis I (SNAPIST-I): a first-in-human safety and dose-finding study. Clin Cardiol. 2007 Apr;30(4):165-70. doi: 10.1002/clc.20066.

  PMID: 17443649 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Eric J Dippel, MD

  Midwest Cardiovascular Research Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric J Dippel, MD

CONTACT

563-324-2828; dippel@cvmedpc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President, Midwest Cardiovascular Foundation

Study Record Dates

• First Submitted: May 13, 2012
• First Posted: May 15, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2014
• Last Updated: May 15, 2012

Record last verified: 2012-05

Locations

US (1)