Effectiveness of Adventitial Dexamethasone in Peripheral Artery Disease

NCT01983449 | Completed Phase 4

• 2 other identifiers: TSP01491142183
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 38

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.

Conditions

Peripheral Arterial Diseases

Keywords

Adventitia; Peripheral Artery Disease; Restenosis; Inflammation; Anti-Inflammatory; Dexamethasone

Outcome Measures

Primary Outcomes (3)

• 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.

  30 days

• 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.

  6 months

• 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.

  12 months

Secondary Outcomes (8)

• Long term safety

  30 days to 6 months

• Duplex ultrasound index lesion flow limiting restenosis

  6 and 12 months

• Change in inflammatory biomarkers

  Baseline and 24 hours

• Vascular patency

  6, 12, 18 and 24 months

• Clinical outcome measures

  1, 6, 12, 18 and 24 months

Study Arms (1)

Adventitial Dexamethasone

EXPERIMENTAL

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

Interventions

Dexamethasone Sodium Phosphate Injection, USP DRUG

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

Adventitial Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mercator MedSystems, Inc.: lead

Study Sites (38)

Arizona Heart Hospital / Abrazo Health Care Research / Tenet Health

Phoenix, Arizona, 85016, United States

Location

Pima Vascular

Tucson, Arizona, 85718, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Cardiovascular Medical Group of Southern California / Cardiovascular Research Foundation

Beverly Hills, California, 90210, United States

Location

St. Joseph Hospital of Orange Heart and Vascular Center

Orange, California, 92868, United States

Location

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

University of California San Francisco Medical Center

San Francisco, California, 94131, United States

Location

VA Eastern Colorado Healthcare System

Denver, Colorado, 80220, United States

Location

Hartford Hospital

Hartford, Connecticut, 06702, United States

Location

MedStar Health Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32216, United States

Location

Munroe Regional Medical Center

Ocala, Florida, 34471, United States

Location

Coastal Vascular & Interventional

Pensacola, Florida, 32504, United States

Location

St. Joseph Hospital

Fort Wayne, Indiana, 46802, United States

Location

Willis-Knighton Medical Center

Shreveport, Louisiana, 71103, United States

Location

UMass Medical School

Worcester, Massachusetts, 01655, United States

Location

St. John Providence Hospital and Medical Center

Detroit, Michigan, 48326, United States

Location

Hattiesburg Clinic

Hattiesburg, Mississippi, 39401, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

St.Louis University Hospital

St Louis, Missouri, 63110, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Deborah Heart & Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Hunterdon Medical Center

Flemington, New Jersey, 08822, United States

Location

Rutgers New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

Albany Vascular Group

Albany, New York, 12208, United States

Location

Gotham Cardiovascular Research / New York Cardiovascular Associates

New York, New York, 10001, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

UNC Health Care - Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

OhioHealth

Columbus, Ohio, 43214, United States

Location

UPMC Heart & Vascular Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37660, United States

Location

DFW Vascular Group

Dallas, Texas, 75208, United States

Location

Plaza Medical Center at Fort Worth

Fort Worth, Texas, 76104, United States

Location

Palestine Regional Medical Center

Palestine, Texas, 75801, United States

Location

Mission Research Institute (Guadalupe Regional Medical Center)

Seguin, Texas, 78155, United States

Location

Alpine Research / Utah Cardiology

Salt Lake City, Utah, 84041, United States

Location

University of Washington Veterans Center

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• 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.

  PMID: 29730377 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Inflammation

Interventions

dexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mahmood Razavi, MD

  St. Joseph's Vascular Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 14, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2018
• Last Updated: March 8, 2018

Record last verified: 2018-03

Locations

US (38)