AzTrials
AzTrials

Peripheral Arterial DiseasesPhase 4DANCENCT01983449

Effectiveness of Adventitial Dexamethasone in Peripheral Artery Disease

A Phase 4 study testing Dexamethasone Sodium Phosphate Injection, USP in people with Peripheral Arterial Diseases, run by Mercator MedSystems, Inc. at 38 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To assess the safety and effectiveness of adventitial deposition of the Study Drug in reducing inflammation and restenosis in patients with clinical evidence of claudication or critical limb ischemia and an angiographically significant lesion in the superficial femoral and/or popliteal arteries. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Arterial Diseases
What is being tested?
Dexamethasone Sodium Phosphate Injection, USP
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
285 participants
Where
38 sitesUnited States
Study dates
Nov 2013to Jan 2018
Phase
Phase 4
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Screening Criteria
  • Male or non-pregnant female ≥18 years of age
  • Rutherford Clinical Category 2-4
  • Clinical diagnosis of PAD requiring revascularization, secondary to atherosclerosis affecting a lower limb
  • Patient is willing to provide informed consent and comply with the required follow up visits, testing schedule, and medication regimen
  • Procedural Criteria
Show all 11Show fewer
  • De novo or nonstented restenotic lesions >90 days from prior angioplasty and/or atherectomy, at least 3 cm from any previously placed stent or vascular surgery site
  • >70% diameter stenosis up to 15 cm in total length (with no greater than 3 cm length of contiguous intervening normal artery) in the superficial femoral and/or popliteal artery (between the profunda and tibioperoneal trunk)
  • Reference vessel diameter ≥3mm and ≤ 8mm
  • Successful wire crossing of lesion
  • A patent artery proximal to the index lesion free from significant stenosis (significant stenosis is defined as >50% in iliac or >30% stenosis in common femoral artery) as confirmed by angiography (treatment of target lesion after successful treatment of iliac or common femoral artery lesions is acceptable)

Who cannot join

  • Screening Criteria
  • Pregnant, nursing or planning on becoming pregnant in < 2 years
  • Life expectancy of <2 years
  • Known active malignancy
  • History of solid organ transplantation
  • Patient actively participating in another investigational device or drug study
Show all 25Show fewer
  • History of hemorrhagic stroke within 3 months
  • Previous or planned surgical or interventional procedure within 30 days of index procedure
  • Chronic renal insufficiency with eGFR <29
  • Prior bypass surgery, stenting of the target lesion
  • Inability to take required study medications
  • Contra-indication or known hypersensitivity to dexamethasone sodium phosphate, contrast media, or Physician prescribed antiplatelet regimen as indicated
  • Systemic fungal infection
  • Anticipated use of IIb/IIIa inhibitor prior to index lesion treatment
  • Acute or sub-acute thrombus, acute vessel occlusion or sudden symptom onset
  • Acute limb ischemia
  • Prior participation of the index limb in the current study (contralateral treatment is allowed)
  • Inability to ambulate (e.g. from prior ipsilateral or contralateral amputation)
  • Patient is receiving steroids already, however locally acting inhaled steroids for asthma treatment do not exclude patients from the trial
  • Procedural Criteria
  • Lesions extending into the trifurcation or above the profunda
  • Heavy eccentric or moderate circumferential calcification at index lesion, which in the judgment of the investigator would prevent penetration of the Micro-Infusion Catheter needle through the vessel wall
  • Lesion length is >15 cm as measured from proximal normal vessel to distal normal vessel, or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured
  • Inadequate distal outflow defined as absence of at least one patent tibial artery (no lesion >50% stenosis) with flow into the foot
  • Use of adjunctive therapies other than angioplasty, atherectomy (mechanical or laser) or bare metal stenting (i.e. scoring/cutting balloon, drug-eluting stent, drug-coated balloon, cryoplasty, etc.)

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

United States38 sites

  • Albany Vascular Group

    Albany, New York, 12208

  • Cardiovascular Medical Group of Southern California / Cardiovascular Research Foundation

    Beverly Hills, California, 90210

  • Deborah Heart & Lung Center

    Browns Mills, New Jersey, 08015

  • OhioHealth

    Columbus, Ohio, 43214

  • DFW Vascular Group

    Dallas, Texas, 75208

  • VA Eastern Colorado Healthcare System

    Denver, Colorado, 80220

  • St. John Providence Hospital and Medical Center

    Detroit, Michigan, 48326

  • Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • St. Joseph Hospital

    Fort Wayne, Indiana, 46802

  • Plaza Medical Center at Fort Worth

    Fort Worth, Texas, 76104

  • Hartford Hospital

    Hartford, Connecticut, 06702

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • First Coast Cardiovascular Institute

    Jacksonville, Florida, 32216

  • Wellmont CVA Heart Institute

    Kingsport, Tennessee, 37660

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • Gotham Cardiovascular Research / New York Cardiovascular Associates

    New York, New York, 10001

  • Columbia University Medical Center

    New York, New York, 10032

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103

  • Munroe Regional Medical Center

    Ocala, Florida, 34471

  • St. Joseph Hospital of Orange Heart and Vascular Center

    Orange, California, 92868

  • Palestine Regional Medical Center

    Palestine, Texas, 75801

  • Coastal Vascular & Interventional

    Pensacola, Florida, 32504

  • Arizona Heart Hospital / Abrazo Health Care Research / Tenet Health

    Phoenix, Arizona, 85016

  • UPMC Heart & Vascular Institute

    Pittsburgh, Pennsylvania, 15232

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • UNC Health Care - Rex Hospital

    Raleigh, North Carolina, 27607

  • Alpine Research / Utah Cardiology

    Salt Lake City, Utah, 84041

  • San Francisco VA Medical Center

    San Francisco, California, 94121

  • University of California San Francisco Medical Center

    San Francisco, California, 94131

  • University of Washington Veterans Center

    Seattle, Washington, 98195

  • Mission Research Institute (Guadalupe Regional Medical Center)

    Seguin, Texas, 78155

  • Willis-Knighton Medical Center

    Shreveport, Louisiana, 71103

  • St.Louis University Hospital

    St Louis, Missouri, 63110

  • Pima Vascular

    Tucson, Arizona, 85718

  • MedStar Health Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • UMass Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: Delivery of Dexamethasone to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization

To assess the safety and effectiveness of adventitial deposition of the Study Drug in reducing inflammation and restenosis in patients with clinical evidence of claudication or critical limb ischemia and an angiographically significant lesion in the superficial femoral and/or popliteal arteries.

Study Drug and Dose: Dexamethasone Sodium Phosphate Injection, USP, 4 mg/ml, with dilute contrast (17%) administered to the adventitia in a dose of 1.6 mg per cm of desired vessel treatment length.

Read the detailed description

This trial will examine the ability for adventitial dexamethasone to safely delay restenosis in patients at least 18 years of age, who have peripheral atherosclerotic lesions involving the superficial femoral and/or popliteal arteries. These patients have no current therapeutic alternatives beyond the procedure used to open, or revascularize, their superficial femoral and/or popliteal arteries. Metal stents have the potential to fracture when implanted in this artery segment due to continual flexion and bending of the knee. It is desirable to improve the patency of this artery after percutaneous transluminal angioplasty (PTA) and/or atherectomy-based revascularization.

Being tested
Dexamethasone Sodium Phosphate Injection, USP
Keywords
Adventitia, Peripheral Artery Disease, Restenosis, Inflammation, Anti-Inflammatory, Dexamethasone
Medical subject headings
Peripheral Arterial Disease, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexamethasone Sodium Phosphate Injection, USPDrug

    Adventitial infusion of dexamethasone after angioplasty or atherectomy-based revascularization of the superficial femoral or popliteal artery.

Study groups in NCT01983449
Study groupRoleWhat they receive
Adventitial DexamethasoneExperimentalIn patients receiving either angioplasty or atherectomy-based revascularization (pre-stratified to each by 50% of the total study), dexamethasone will be delivered to the adventitia following revascularization.
Receives: Drug: Dexamethasone Sodium Phosphate Injection, USP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MALE-POD

    Acute safety safety outcomes will be determined by evaluating the type, frequency, severity, and relatedness of Major Adverse Limb Events or Peri-Operative Death (MALE+POD) within 30 days from the procedure for all subjects.

    Measured: 30 days

  2. Duplex ultrasound index lesion binary restenosis

    Binary restenosis will be judged by core laboratory interpretation with peak systolic velocity ratio (PSVR) greater than 2.4.

    Measured: 6 months

  3. Duplex ultrasound index lesion binary restenosis

    Binary restenosis will be judged by core laboratory interpretation with peak systolic velocity ratio (PSVR) greater than 2.4.

    Measured: 12 months

Secondary outcomes (8)

  1. Long term safety

    Long term safety outcomes that occur after 30 days through 6 months post-procedure will be determined by evaluating adverse events.

    Measured: 30 days to 6 months

  2. Duplex ultrasound index lesion flow limiting restenosis

    Flow limiting restenosis will be judged by core laboratory as PSVR>4.0.

    Measured: 6 and 12 months

  3. Change in inflammatory biomarkers

    Change in inflammatory biomarkers will be measured with a panel of biomarkers in 1/3 of patients.

    Measured: Baseline and 24 hours

  4. Vascular patency

    Target lesion revascularization (TLR) rate, target extremity revascularization (TER) rate, limb salvage rate and primary patency (PSVR≤2.4 and no TLR) at 6, 12, 18 and 24 months. Note: provisional stenting performed during the index procedure shall not be considered to be TLR, TER or loss of primary patency.

    Measured: 6, 12, 18 and 24 months

  5. Clinical outcome measures

    Modified Walking Impairment Questionnaire, Ankle-Brachial Index, Rutherford Score.

    Measured: 1, 6, 12, 18 and 24 months

  6. Infusion Technical Success

    Distribution grade around infusion sites.

    Measured: Intraprocedural

  7. Procedural Success

    Establishment of antegrade flow with residual stenosis of <30% by angiogram.

    Measured: Intraprocedural

  8. Healthcare Economics

    Number of return visits and hospitalizations, time from index procedure to required revascularization and number of index-lesion-related readmissions within 30 days will be measured.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionDec 2016
  4. Study completionJan 2018

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
285 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01983449
Sponsor's protocol ID
TSP0149
Other IDs
1142183
Acronym
DANCE
Status last verified
Mar 2018
First submitted
4 Nov 2013
Last updated
8 Mar 2018
Results posted
No
Data monitoring committee
No

Publications

  • Razavi MK, Donohoe D, D'Agostino RB Jr, Jaff MR, Adams G; DANCE Investigators. Adventitial Drug Delivery of Dexamethasone to Improve Primary Patency in the Treatment of Superficial Femoral and Popliteal Artery Disease: 12-Month Results From the DANCE Clinical Trial. JACC Cardiovasc Interv. 2018 May 28;11(10):921-931. doi: 10.1016/j.jcin.2017.12.015. Epub 2018 May 2.

    PubMed 29730377

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexamethasone Sodium Phosphate Injection, USP in people with Peripheral Arterial Diseases, run by Mercator MedSystems, Inc. at 38 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 11 inclusion and 25 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 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

MALE-POD (time frame: 30 days). The study lists 3 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 NCT01983449, 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 Mar 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in