Peripheral Arterial DiseaseDANCENCT01507558
Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization
A study testing Administration of dexamethasone to SFA/popliteal adventitia in people with Peripheral Arterial Disease, run by University of California, San Francisco at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Administration of dexamethasone to SFA/popliteal adventitia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2010to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
San Francisco VA Medical Center
San Francisco, California, 94121
University of California, San Francisco Medical Center
San Francisco, California, 94143
About this study
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.
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Administration of dexamethasone to SFA/popliteal adventitia
- Keywords
- Peripheral Arterial Disease, Femoral popliteal lesions
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of dexamethasone to SFA/popliteal adventitiaProcedure or surgery
Also called angioplasty, atherectomy, TASC II A, B, C lesion, dexamethasone
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Perivascular administration of dexamethasone following endovascular superficial femoral and popliteal artery angioplasty or atherectomy. Receives: Procedure: Administration of dexamethasone to SFA/popliteal adventitia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Outcome Measures:
Freedom from death, vessel dissection, thrombosis or extravasation at 30 days post-procedure.
Measured: 30 days
Effectiveness Outcome Measures:
Freedom from Target Lesion Revascularization (TLR) and/or Target Vessel Revascularization (TVR) at 6 months post-procedure.
Measured: 6 months
Secondary outcomes (1)
Safety Outcome Measures:
Freedom from death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startDec 2010
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Warren J. Gasper, MD, University of California, San Francisco
- Investigators
- Warren J. Gasper, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507558
- Sponsor's protocol ID
- 10-02101
- Acronym
- DANCE
- Status last verified
- Jan 2018
- First submitted
- 9 Nov 2011
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24423476
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization
- ClinicalTrials.gov ID
- NCT01507558
- Acronym / sponsor ID
- DANCE / 10-02101
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral Arterial Disease, Femoral popliteal lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Administration of dexamethasone to SFA/popliteal adventitiaPerivascular administration of dexamethasone following endovascular superficial femoral and popliteal artery angioplasty or atherectomy. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of dexamethasone to SFA/popliteal adventitiaAlso: angioplasty, atherectomy, TASC II A, B, C lesion, dexamethasoneFollowing 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. | Procedure or surgery | Intervention |
Primary outcome
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.
1 secondary outcome
Safety Outcome Measures:
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
- Derived from this study: PubMed 24423476Owens 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warren J. Gasper, M.D. principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of dexamethasone to SFA/popliteal adventitia in people with Peripheral Arterial Disease, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Outcome Measures: (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01507558, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2018.