Effectiveness of Adventitial Dexamethasone in Peripheral Artery Disease

NCT ID: NCT01983449

Last Updated: 2018-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 285 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2018-01-31

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.

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.

Conditions

Peripheral Arterial Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Dexamethasone Sodium Phosphate Injection, USP

Intervention Type: DRUG

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

Interventions

Dexamethasone Sodium Phosphate Injection, USP

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

Intervention Type: DRUG

Eligibility 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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mercator MedSystems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mahmood Razavi, MD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Vascular Institute

Locations

Arizona Heart Hospital / Abrazo Health Care Research / Tenet Health

Phoenix, Arizona, United States

Pima Vascular

Tucson, Arizona, United States

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Cardiovascular Medical Group of Southern California / Cardiovascular Research Foundation

Beverly Hills, California, United States

St. Joseph Hospital of Orange Heart and Vascular Center

Orange, California, United States

San Francisco VA Medical Center

San Francisco, California, United States

University of California San Francisco Medical Center

San Francisco, California, United States

VA Eastern Colorado Healthcare System

Denver, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

MedStar Health Washington Hospital Center

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

First Coast Cardiovascular Institute

Jacksonville, Florida, United States

Munroe Regional Medical Center

Ocala, Florida, United States

Coastal Vascular & Interventional

Pensacola, Florida, United States

St. Joseph Hospital

Fort Wayne, Indiana, United States

Willis-Knighton Medical Center

Shreveport, Louisiana, United States

UMass Medical School

Worcester, Massachusetts, United States

St. John Providence Hospital and Medical Center

Detroit, Michigan, United States

Hattiesburg Clinic

Hattiesburg, Mississippi, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

St.Louis University Hospital

St Louis, Missouri, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Deborah Heart & Lung Center

Browns Mills, New Jersey, United States

Hunterdon Medical Center

Flemington, New Jersey, United States

Rutgers New Jersey Medical School

Newark, New Jersey, United States

Albany Vascular Group

Albany, New York, United States

Gotham Cardiovascular Research / New York Cardiovascular Associates

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

UNC Health Care - Rex Hospital

Raleigh, North Carolina, United States

OhioHealth

Columbus, Ohio, United States

UPMC Heart & Vascular Institute

Pittsburgh, Pennsylvania, United States

The Miriam Hospital

Providence, Rhode Island, United States

Wellmont CVA Heart Institute

Kingsport, Tennessee, United States

DFW Vascular Group

Dallas, Texas, United States

Plaza Medical Center at Fort Worth

Fort Worth, Texas, United States

Palestine Regional Medical Center

Palestine, Texas, United States

Mission Research Institute (Guadalupe Regional Medical Center)

Seguin, Texas, United States

Alpine Research / Utah Cardiology

Salt Lake City, Utah, United States

University of Washington Veterans Center

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29730377 (View on PubMed)

Other Identifiers

1142183

Identifier Type: OTHER

Identifier Source: secondary_id

TSP0149

Identifier Type: -

Identifier Source: org_study_id