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

NCT01507558 | Completed DMC

• 1 other identifier: 10-02101
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease; Femoral popliteal lesions

Outcome Measures

Primary Outcomes (2)

• Safety Outcome Measures:

  Freedom from death, vessel dissection, thrombosis or extravasation at 30 days post-procedure.

  30 days

• Effectiveness Outcome Measures:

  Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 6 months post-procedure.

  6 months

Secondary Outcomes (1)

• Safety Outcome Measures:

  24 months

Study Arms (1)

Intervention

EXPERIMENTAL

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

Procedure: Administration of dexamethasone to SFA/popliteal adventitia

Interventions

Administration of dexamethasone to SFA/popliteal adventitia PROCEDURE

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.

Also known as: angioplasty, atherectomy, TASC II A, B, C lesion, dexamethasone, superficial femoral artery, popliteal artery

Intervention

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (2)

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

University of California, San Francisco Medical Center

San Francisco, California, 94143, United States

Location

Related Publications (1)

• 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.

  PMID: 24423476 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Angioplasty; Atherectomy; Dexamethasone

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Warren J. Gasper, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: January 11, 2012
• Study Start: December 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: January 8, 2018

Record last verified: 2018-01

Locations

US (2)