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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01507558
First received: November 9, 2011
Last updated: October 20, 2015
Last verified: October 2015
History of Changes
  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:

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 2017
Estimated Primary Completion Date: June 2016 (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

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   (Adult, Senior)
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

Locations
United States, California
San Francisco VA Medical Center
San Francisco, California, United States, 94121
University of California, San Francisco Medical Center
San Francisco, California, United States, 94143
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

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

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: October 20, 2015
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
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 27, 2016