Overview

This trial is active, not recruiting.

Condition peripheral arterial disease
Treatment administration of dexamethasone to sfa/popliteal adventitia
Sponsor University of California, San Francisco
Start date December 2010
End date June 2016
Trial size 30 participants
Trial identifier NCT01507558, 10-02101

Summary

The purpose of this study is to test if dexamethasone, an anti-inflammatory medication approved by the US Food and Drug Administration (FDA), can be injected safely into the tissue around the blood vessel wall at the time of an angioplasty or atherectomy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Perivascular administration of dexamethasone following endovascular superficial femoral and popliteal artery angioplasty or atherectomy.
administration of dexamethasone to sfa/popliteal adventitia angioplasty
Following a balloon angioplasty or atherectomy of a stenotic TASC II A, B, or C lesion in the superficial femoral or popliteal artery, a Bullfrog Micro-Infusion Catheter will be used to infuse 0.96 mg dexamethasone per cm arterial lesion.

Primary Outcomes

Measure
Safety Outcome Measures:
time frame: 30 days
Effectiveness Outcome Measures:
time frame: 6 months

Secondary Outcomes

Measure
Safety Outcome Measures:
time frame: 24 months

Eligibility Criteria

Male or female participants from 40 years up to 80 years old.

Inclusion Criteria: - Patient is > 40 years and < 80 years of age - Patient has severe, lifestyle-limiting claudication or critical limb ischemia (Rutherford classification 3-6) - Patient has TASC II A, B or C disease, SFA revascularization is preferred over medical management, and endovascular approach is preferred revascularization strategy - Patient has a resting ABI of <0.9 or an abnormal treadmill ABI. Patients with incompressible arteries must have a TBI <0.8 - Patient has at least 1 infra-popliteal run-off vessel with patency to the ankle without a >50% stenosis - Successful crossing of the lesion with guidewire and successful atherectomy or angioplasty with residual stenosis <30% as compared to the reference vessels - Atherectomy procedure does not result in embolization, arteriovenous fistula or perforation - Patient agrees to return for a clinical assessment duplex ultrasound at 1, 3, 6, 9, 12 and 24 months (routine clinical care) Exclusion Criteria: - Patient is simultaneously participating in another investigational drug or device study - Patient is pregnant or breast-feeding - Patient has cancer, autoimmune disease, bone marrow or organ transplant, or other concurrent medical illness requiring immunosuppressive therapy - Patient has end-stage renal disease and chronic kidney disease (eGFR<30) - Patient has an active infection - Patient has a known hypersensitivity or contraindication to heparin, contrast agents, excipients of Dexamethasone Sodium Phosphate Injection, USP, dexamethasone, or other glucocorticoids - Patient has a life expectancy of less than one year

Additional Information

Official title Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization
Principal investigator Christopher D Owens, M.D., M.Sc
Description This is an investigator-initiated, single-arm, external pilot study to assess the safety and feasibility of perivascular administration of dexamethasone following endovascular superficial femoral and popliteal artery angioplasty or atherectomy. Although dexamethasone is approved by the FDA for injection into blood, skin or joints, it has not been approved by the FDA for injection around blood vessels. The investigators want to find out if this procedure helps prevent re-narrowing of the blood vessel after angioplasty or atherectomy. The dexamethasone will be injected with a Bullfrog® Micro-Infusion catheter, which is an FDA-approved device for injecting medications into tissues around the blood vessel wall. The Bullfrog® Micro-Infusion catheter is similar to other balloon tipped catheters except that it contains a microneedle covered by a fold of semi-rigid balloon. Once the balloon is inflated, the microneedle is uncovered and a medication can be injected into the tissue around the blood vessel.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of California, San Francisco.