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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:
University of California, San Francisco
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
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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: | 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:
Further study details as provided by University of California, San Francisco:
Primary Outcome Measures:
- Safety Outcome Measures: [ Time Frame: 30 days ]Freedom from death, vessel dissection, thrombosis or extravasation at 30 days post-procedure.
- Effectiveness Outcome Measures: [ Time Frame: 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: [ Time Frame: 24 months ]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:
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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) |
| Sexes Eligible for Study: | All |
| 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
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 |
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 June 22, 2017