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

NCT01298947 | Unknown DMC

• 1 other identifier: PHOTOPAC
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Restenosis

Keywords

Photoablative Atherectomy; Paclitaxel-Coated Balloon; Instent Femoro-popliteal Obstructions

Outcome Measures

Primary Outcomes (1)

• Target Lesion Percent Stenosis

  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.

  at 1 Year

Secondary Outcomes (1)

• Procedural Success

  at 1 year

Study Arms (2)

Laser atherectomy and drug-coated balloon

ACTIVE COMPARATOR

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

Drug eluting Ballon PTA

ACTIVE COMPARATOR

Paclitaxel-coated balloon angioplasty

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

Interventions

Laser Atherectomy (Spectranetics CE marked peripheral laser atherectomy catheters (including Turbo Elite®), Turbo-Booster® and Turbo Tandem™ Systems DEVICE

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

Drug eluting Ballon PTA; Laser atherectomy and drug-coated balloon

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Has contraindications listed in any study device IFUs.
• Has a contraindication or known untreated allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs or any other drug anticipated to be used.
• Has a hypersensitivity to contrast material that cannot be adequately pretreated.
• Has known hypersensitivity to treatment device materials including Paclitaxel. Has known uncontrollable hypercoagulable condition, or refuses blood transfusion.
• \. Has life expectancy of less than 12 months. 7. Is pregnant, of childbearing potential not taking adequate contraceptives, or nursing.
• \. Has surgical or endovascular procedure of the target vessel within 14 days prior to the index procedure.
• \. Has any planned surgical intervention (requiring hospitalization) or endovascular procedure within 30 days after the index procedure.
• \. Is currently participating in an investigational drug or another device study that may clinically interfere with the study outcomes.
• \. Any co-morbid condition that in the judgment of the physician precludes safe percutaneous intervention.
• \. 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).
• \. Is unable or unwilling to receive dual anti-platelet therapy. 15. Equipment is unavailable to fulfill study treatments.

Sponsors & Collaborators

• Herz-Zentrums Bad Krozingen: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: February 18, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: February 21, 2011

Record last verified: 2011-02