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Effectiveness of Adventitial Dexamethasone in Peripheral Artery Disease (DANCE)

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ClinicalTrials.gov Identifier: NCT01983449
Recruitment Status : Completed
First Posted : November 14, 2013
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Mercator MedSystems, Inc.

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Peripheral Arterial Diseases Drug: Dexamethasone Sodium Phosphate Injection, USP Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Delivery of Dexamethasone to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization
Study Start Date : November 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2018


Arm Intervention/treatment
Experimental: Adventitial Dexamethasone
In 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.
Drug: Dexamethasone Sodium Phosphate Injection, USP
Adventitial infusion of dexamethasone after angioplasty or atherectomy-based revascularization of the superficial femoral or popliteal artery.




Primary Outcome Measures :
  1. MALE-POD [ Time Frame: 30 days ]
    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.

  2. Duplex ultrasound index lesion binary restenosis [ Time Frame: 6 months ]
    Binary restenosis will be judged by core laboratory interpretation with peak systolic velocity ratio (PSVR) greater than 2.4.

  3. Duplex ultrasound index lesion binary restenosis [ Time Frame: 12 months ]
    Binary restenosis will be judged by core laboratory interpretation with peak systolic velocity ratio (PSVR) greater than 2.4.


Secondary Outcome Measures :
  1. Long term safety [ Time Frame: 30 days to 6 months ]
    Long term safety outcomes that occur after 30 days through 6 months post-procedure will be determined by evaluating adverse events.

  2. Duplex ultrasound index lesion flow limiting restenosis [ Time Frame: 6 and 12 months ]
    Flow limiting restenosis will be judged by core laboratory as PSVR>4.0.

  3. Change in inflammatory biomarkers [ Time Frame: Baseline and 24 hours ]
    Change in inflammatory biomarkers will be measured with a panel of biomarkers in 1/3 of patients.

  4. Vascular patency [ Time Frame: 6, 12, 18 and 24 months ]
    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.

  5. Clinical outcome measures [ Time Frame: 1, 6, 12, 18 and 24 months ]
    Modified Walking Impairment Questionnaire, Ankle-Brachial Index, Rutherford Score.

  6. Infusion Technical Success [ Time Frame: Intraprocedural ]
    Distribution grade around infusion sites.

  7. Procedural Success [ Time Frame: Intraprocedural ]
    Establishment of antegrade flow with residual stenosis of <30% by angiogram.

  8. Healthcare Economics [ Time Frame: 30 days ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

    • 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)

Exclusion Criteria:

  • 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
    • 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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01983449


  Hide Study Locations
Locations
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United States, Arizona
Arizona Heart Hospital / Abrazo Health Care Research / Tenet Health
Phoenix, Arizona, United States, 85016
Pima Vascular
Tucson, Arizona, United States, 85718
United States, Arkansas
Arkansas Heart Hospital
Little Rock, Arkansas, United States, 72211
United States, California
Cardiovascular Medical Group of Southern California / Cardiovascular Research Foundation
Beverly Hills, California, United States, 90210
St. Joseph Hospital of Orange Heart and Vascular Center
Orange, California, United States, 92868
San Francisco VA Medical Center
San Francisco, California, United States, 94121
University of California San Francisco Medical Center
San Francisco, California, United States, 94131
United States, Colorado
VA Eastern Colorado Healthcare System
Denver, Colorado, United States, 80220
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06702
United States, District of Columbia
MedStar Health Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
First Coast Cardiovascular Institute
Jacksonville, Florida, United States, 32216
Munroe Regional Medical Center
Ocala, Florida, United States, 34471
Coastal Vascular & Interventional
Pensacola, Florida, United States, 32504
United States, Indiana
St. Joseph Hospital
Fort Wayne, Indiana, United States, 46802
United States, Louisiana
Willis-Knighton Medical Center
Shreveport, Louisiana, United States, 71103
United States, Massachusetts
UMass Medical School
Worcester, Massachusetts, United States, 01655
United States, Michigan
St. John Providence Hospital and Medical Center
Detroit, Michigan, United States, 48326
United States, Mississippi
Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
St.Louis University Hospital
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03766
United States, New Jersey
Deborah Heart & Lung Center
Browns Mills, New Jersey, United States, 08015
Hunterdon Medical Center
Flemington, New Jersey, United States, 08822
Rutgers New Jersey Medical School
Newark, New Jersey, United States, 07103
United States, New York
Albany Vascular Group
Albany, New York, United States, 12208
Gotham Cardiovascular Research / New York Cardiovascular Associates
New York, New York, United States, 10001
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
UNC Health Care - Rex Hospital
Raleigh, North Carolina, United States, 27607
United States, Ohio
OhioHealth
Columbus, Ohio, United States, 43214
United States, Pennsylvania
UPMC Heart & Vascular Institute
Pittsburgh, Pennsylvania, United States, 15232
United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, Tennessee
Wellmont CVA Heart Institute
Kingsport, Tennessee, United States, 37660
United States, Texas
DFW Vascular Group
Dallas, Texas, United States, 75208
Plaza Medical Center at Fort Worth
Fort Worth, Texas, United States, 76104
Palestine Regional Medical Center
Palestine, Texas, United States, 75801
Mission Research Institute (Guadalupe Regional Medical Center)
Seguin, Texas, United States, 78155
United States, Utah
Alpine Research / Utah Cardiology
Salt Lake City, Utah, United States, 84041
United States, Washington
University of Washington Veterans Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Mercator MedSystems, Inc.
Investigators
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Principal Investigator: Mahmood Razavi, MD St. Joseph's Vascular Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mercator MedSystems, Inc.
ClinicalTrials.gov Identifier: NCT01983449     History of Changes
Other Study ID Numbers: TSP0149
1142183 ( Other Identifier: Western IRB )
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Keywords provided by Mercator MedSystems, Inc.:
Adventitia
Peripheral Artery Disease
Restenosis
Inflammation
Anti-Inflammatory
Dexamethasone
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Dexamethasone
Dexamethasone acetate
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