DANCE: Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT01507558

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease	Procedure: Administration of dexamethasone to SFA/popliteal adventitia	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization

Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Perivascular administration of dexamethasone following endovascular superficial femoral and popliteal artery angioplasty or atherectomy.	Procedure: Administration of dexamethasone to SFA/popliteal adventitia 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. Other Names: angioplasty atherectomy TASC II A, B, C lesion dexamethasone superficial femoral artery popliteal artery

Arm

Intervention/Treatment

Experimental: Intervention

Perivascular administration of dexamethasone following endovascular superficial femoral and popliteal artery angioplasty or atherectomy.

Procedure: Administration of dexamethasone to SFA/popliteal adventitia

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.

Other Names:

angioplasty

atherectomy

TASC II A, B, C lesion

dexamethasone

superficial femoral artery

popliteal artery

Outcome Measures

Primary Outcome Measures

Safety Outcome Measures: [30 days]
Freedom from death, vessel dissection, thrombosis or extravasation at 30 days post-procedure.
Effectiveness Outcome Measures: [6 months]
Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 6 months post-procedure.

Secondary Outcome Measures

Safety Outcome Measures: [24 months]
Freedom from death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Francisco VA Medical Center	San Francisco	California	United States	94121
2	University of California, San Francisco Medical Center	San Francisco	California	United States	94143