Photoablative Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis in Instent Femoro-popliteal Obstructions (PHOTOPAC)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Herz-Zentrums Bad Krozingen
ClinicalTrials.gov Identifier:
NCT01298947
First received: February 17, 2011
Last updated: February 18, 2011
Last verified: February 2011
  Purpose

The objective of this study is to evaluate the safety and efficacy of preparing a vessel with photoablation with Spectranetics CVX-300® Excimer laser and laser catheters prior to local Paclitaxel delivery compared to local Paclitaxel delivery without initial photoablation


Condition Intervention
Restenosis
Device: Laser Atherectomy (Spectranetics CE marked peripheral laser atherectomy catheters (including Turbo Elite®), Turbo-Booster® and Turbo Tandem™ Systems

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Photoablative Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis in Instent Femoro-popliteal Obstructions

Resource links provided by NLM:


Further study details as provided by Herz-Zentrums Bad Krozingen:

Primary Outcome Measures:
  • Target Lesion Percent Stenosis [ Time Frame: at 1 Year ] [ Designated as safety issue: No ]
    Target Lesion Percent Stenosis at 1 Year: Defined as the narrowest point of the target lesion divided by the estimated native vessel diameter at that location as determined by the angiographic core lab.


Secondary Outcome Measures:
  • Procedural Success [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]

    Defined as ≤ 30% residual stenosis following the procedure at the target lesion, without periprocedural complications, as determined by the angiographic core lab.

    Major Adverse Event Rate at 30 Days and 1 Year: Defined as, major unplanned amputation of the treated limb, all-cause mortality within 1 year of the index procedure or clinically-driven target vessel revascularization within 30 days and 1 year of the index procedure.



Estimated Enrollment: 50
Study Start Date: April 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Laser atherectomy and drug-coated balloon
Laser atherectomy and Paclitaxel-coated balloon angioplasty in treatment of instent lesions of femoropopliteal arteries
Device: Laser Atherectomy (Spectranetics CE marked peripheral laser atherectomy catheters (including Turbo Elite®), Turbo-Booster® and Turbo Tandem™ Systems
comparing the use of a Paclitaxel-eluting angioplasty balloon (PTX PTA) with initial photoablation to the use of PTX PTA alone in the treatment of instent lesions in femoropopliteal arteries
Active Comparator: Drug eluting Ballon PTA
Paclitaxel-coated balloon angioplasty
Device: Laser Atherectomy (Spectranetics CE marked peripheral laser atherectomy catheters (including Turbo Elite®), Turbo-Booster® and Turbo Tandem™ Systems
comparing the use of a Paclitaxel-eluting angioplasty balloon (PTX PTA) with initial photoablation to the use of PTX PTA alone in the treatment of instent lesions in femoropopliteal arteries

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must meet all of the following general inclusion criteria.

    1. Has a Rutherford Clinical Category Score of 1 - 5.
    2. Is willing and capable of complying with all follow-up evaluations at the specified times.
    3. Is ≥ 18 years old.
    4. Provides written informed consent prior to study specific procedures.

Exclusion Criteria:

  • The subject must not meet any of the following general exclusion criteria.

    1. Has contraindications listed in any study device IFUs.
    2. Has a contraindication or known untreated allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs or any other drug anticipated to be used.
    3. Has a hypersensitivity to contrast material that cannot be adequately pretreated.
    4. Has known hypersensitivity to treatment device materials including Paclitaxel. Has known uncontrollable hypercoagulable condition, or refuses blood transfusion.

    6. Has life expectancy of less than 12 months. 7. Is pregnant, of childbearing potential not taking adequate contraceptives, or nursing.

    8. Has surgical or endovascular procedure of the target vessel within 14 days prior to the index procedure.

    9. Has any planned surgical intervention (requiring hospitalization) or endovascular procedure within 30 days after the index procedure.

    10. Is currently participating in an investigational drug or another device study that may clinically interfere with the study outcomes.

    11. Any co-morbid condition that in the judgment of the physician precludes safe percutaneous intervention.

    12. Has had a previous peripheral bypass affecting the target vessel. 13. Has chronic renal insufficiency with creatinine > 2.5 mg/L (except patients under chronic renal replacement therapy).

    14. Is unable or unwilling to receive dual anti-platelet therapy. 15. Equipment is unavailable to fulfill study treatments.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Prof. Dr. Thomas Zeller, Herz-Zentrum Bad Krozingen
ClinicalTrials.gov Identifier: NCT01298947     History of Changes
Other Study ID Numbers: PHOTOPAC
Study First Received: February 17, 2011
Last Updated: February 18, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Herz-Zentrums Bad Krozingen:
Photoablative Atherectomy
Paclitaxel-Coated Balloon
Instent Femoro-popliteal Obstructions

Additional relevant MeSH terms:
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014