Intima Versus Adventitia Drug Delivery to Elucidate Mechanisms of Restenosis: Magnetic Resonance Imaging

NCT02807779 | Completed Phase 4 Results DMC FDA Drug FDA Device

• 2 other identifiers: 15-172511R01HL128816-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective, multicenter, randomized trial to determine the mechanisms of vascular healing. The study will evaluate subjects with peripheral artery disease (PAD) who require an endovascular intervention of the femoro-popliteal (SFA) artery to restore blood flow to the leg.

Conditions

Peripheral Artery Disease; Vascular Disease; Critical Limb Ischemia

Keywords

angioplasty; peripheral artery disease; peripheral vascular disease; atherosclerosis; balloon angioplasty; dexamethasone; drug coated balloon; paclitaxel; walking; claudication

Outcome Measures

Primary Outcomes (1)

• Change in Percent Wall Volume (PWV)

  The change in percent wall volume (PWV) of the treated segment between the postoperative and 12 month time points as measured by MRI

  From Post-Operative Day One to 12 Months

Secondary Outcomes (7)

• Change in Wall Volume (WV) Without a Change in Total Vessel Volume (TVV)

  From Post-Operative Day One to 12 Months

• Change in Perioperative Inflammatory Profile (MCP-1)

  From Post-Operative Day One to 12 Months

• Change in Perioperative Inflammatory Profile (CRP)

  From Post-Operative Day One to 12 Months

• Change in Perioperative Inflammatory Profile (IL-1beta)

  From Post-Operative Day One to 12 Months

• Change in Transfer Constant (Ktrans)

  From 1 Month to 6 Months

Other Outcomes (1)

• Extended Clinical Adverse Events Monitoring

  From Post-Operative Day One to 36 Months

Study Arms (3)

Dexamethasone

EXPERIMENTAL

Participants randomized to the Dexamethasone group will receive dexamethasone infusion to the adventitia of the artery following plain-old-balloon-angioplasty (POBA).

Drug: Dexamethasone infusion

Drug Coated Balloon

ACTIVE COMPARATOR

Participants randomized to the Drug Coated Balloon (DCB) group will not receive dexamethasone infusion to the adventitia of the artery following (POBA). They will receive additional angioplasty with a paclitaxel coated balloon.

Device: Drug coated balloon

Plain Balloon Angioplasty

ACTIVE COMPARATOR

Participants randomized to the Plain Balloon Angioplasty will receive balloon angioplasty (POBA) only. They will not receive a dexamethasone infusion to the adventitia or paclitaxel.

Device: Plain balloon angioplasty

Interventions

Dexamethasone infusion DRUG

Participants will receive dexamethasone infusion following plain balloon angioplasty

Also known as: microinfusion catheter

Dexamethasone

Drug coated balloon DEVICE

Participants will receive angioplasty with a drug-coated balloon following plain balloon angioplasty

Drug Coated Balloon

Plain balloon angioplasty DEVICE

Participants will receive plain balloon angioplasty only

Plain Balloon Angioplasty

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Screening:
• Male or non-pregnant female ≥ 35 years of age
• Atherosclerotic, infrainguinal PAD
• Rutherford Clinical Category 2-6
• Stenosis detected by radiology that in the clinician's opinion is the reason for the PAD symptoms
• Patient is willing to provide informed consent and comply with the required follow up visits, testing schedule, and medication regimen
• Estimated Glomerular Filtration Rate (eGFR) ≥ 30 and/or threshold established by the local Institutional Review Board or Committee of Human Research
• Procedural Criteria:
• De novo atherosclerotic lesion qualifying for angioplasty
• A patent artery proximal to the index lesion. Concomitant inflow procedures, including open femoral artery endarterectomy and/or stenting of the iliac arteries, are permissible.
• \>50% diameter stenosis of the superficial femoral artery and/or popliteal artery (between the profunda and tibioperoneal trunk)
• Reference vessel diameter ≥3 mm and ≤ 8mm
• Successful wire crossing of lesion
• Successful angioplasty of the index lesion or part of the index lesion, defined as ≤30% residual lumen stenosis compared with adjacent non-diseased lumen diameter, without flow-limiting dissection

You may not qualify if:

• Screening Criteria:
• Any contraindication to receiving an MRI
• Pregnant, nursing, or planning on becoming pregnant in \< 2yrs
• Life expectancy of \< 1 yr
• History of solid organ transplantation
• Patient actively participating in another investigational device or drug study
• History of hemorrhagic stroke within 3 months of index procedure
• Previous or planned surgical or interventional procedure within 30 days of index procedure
• Chronic renal insufficiency with eGFR \< 30
• Prior bypass surgery, stenting, atherectomy or angioplasty of the index lesion
• Inability to take required study medications
• Contra-indication or known hypersensitivity to dexamethasone sodium phosphate, contrast media, gadolinium, aspirin or Plavix
• Systemic fungal infection
• Acute limb ischemia
• Prior participation of the index limb in the current study (contralateral treatment is allowed)

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of Washington: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

San Francisco VA Medical Center

San Francisco, California, 94121, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Vascular Diseases; Chronic Limb-Threatening Ischemia; Peripheral Vascular Diseases; Atherosclerosis; Intermittent Claudication

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Signs and Symptoms

Results Point of Contact

• Title: Warren Gasper, MD
• Organization: University of California, San Francisco

warren.gasper@ucsf.edu

415-353-4366

Study Officials

• Warren Gasper, MD

  San Francisco VA Medical Center

  PRINCIPAL INVESTIGATOR

• David Saloner, PhD

  San Francisco VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2016
• First Posted: June 21, 2016
• Study Start: February 10, 2016
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2022
• Last Updated: July 17, 2025
• Results First Posted: July 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)