Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization - Full Text View

Purpose

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	Intervention
Peripheral Arterial Disease	Procedure: Administration of dexamethasone to SFA/popliteal adventitia


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Peripheral Arterial Disease

Drug Information available for: Dexamethasone Dexamethasone sodium phosphate Dexamethasone acetate

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Safety Outcome Measures: [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Freedom from death, vessel dissection, thrombosis or extravasation at 30 days post-procedure.
Effectiveness Outcome Measures: [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 6 months post-procedure.

Secondary Outcome Measures:

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


Estimated Enrollment:	30
Study Start Date:	December 2010
Estimated Study Completion Date:	June 2016
Estimated Primary Completion Date:	June 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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.

Eligibility


Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507558

Contacts


Contact: Hugh Alley	415-221-4810 ext 4708	Hugh.Alley@ucsfmedctr.org
Contact: Christine Hall	415-221-4810 ext 2115	Christine.Hall@va.gov

Locations


United States, California
San Francisco VA Medical Center	Recruiting
San Francisco, California, United States, 94121
Principal Investigator: Christopher D Owens, M.D., M.Sc
University of California, San Francisco Medical Center	Recruiting
San Francisco, California, United States, 94143
Sub-Investigator: Warren Gasper, M.D.

Sponsors and Collaborators

University of California, San Francisco

Investigators


Principal Investigator:	Christopher D Owens, M.D., M.Sc	University of California, San Francisco

More Information

No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Owens CD, Gasper WJ, Walker JP, Alley HF, Conte MS, Grenon SM. Safety and feasibility of adjunctive dexamethasone infusion into the adventitia of the femoropopliteal artery following endovascular revascularization. J Vasc Surg. 2014 Apr;59(4):1016-24. doi: 10.1016/j.jvs.2013.10.051. Epub 2014 Jan 11.


Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT01507558 History of Changes
Other Study ID Numbers:	10-02101
Study First Received:	November 9, 2011
Last Updated:	August 15, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:


Peripheral Arterial Disease Femoral popliteal lesions

Additional relevant MeSH terms:


Peripheral Arterial Disease Peripheral Vascular Diseases Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Vascular Diseases BB 1101 Dexamethasone Dexamethasone 21-phosphate Dexamethasone acetate Anti-Inflammatory Agents Antiemetics Antineoplastic Agents	Antineoplastic Agents, Hormonal Autonomic Agents Central Nervous System Agents Enzyme Inhibitors Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Protease Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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