AzTrials
AzTrials

Peripheral Artery DiseasePhase 4INVADER_MRINCT02807779

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

A Phase 4 study testing Dexamethasone infusion, Drug coated balloon and Plain balloon angioplasty in people with Peripheral Artery Disease and Vascular Disease, run by University of California, San Francisco at 2 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

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. Read more about this study

Who is it for?
Ages 35 years and older
What is being tested?
Dexamethasone infusion, Drug coated balloon and Plain balloon angioplasty
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
2 sitesUnited States
Study dates
10 Feb 2016to 31 Oct 2022
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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)
  • Patient is being treated with long-term steroids (not including treatment of a bronchial condition with inhaled steroids)
  • Procedural Criteria:
  • Index lesions extending into the tibial trifurcation or above the profunda. Note: the outflow tibial artery can be treated concomitantly. Similarly, the common femoral artery can be treated concomitantly, either with open endarterectomy and patch angioplasty or with endovascular methods. However, the index lesion cannot be contiguous with either the common femoral artery or the tibial trifurcation.
  • 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
  • Inadequate distal outflow defined as no patent tibial arteries (>50% stenosis). The outflow vessel can be established at the time of primary treatment
  • Use of adjunctive therapies other than angioplasty. Chocolate balloons and/or scoring balloons are allowed, if used below reference diameter.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • San Francisco VA Medical Center

    San Francisco, California, 94121

  • University of Washington

    Seattle, Washington, 98104

Other trials in United States

About this study

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.

Read the detailed description

Peripheral artery disease (PAD) affects at least 12 million Americans annually with more than half a million patients undergoing an endovascular or surgical revascularization procedure in order to treat the disease. Unfortunately, about two-thirds of patients still have blockages in the leg arteries, even after these procedures.

Advances in Magnetic resonance imaging (MRI) offer promise for understanding the mechanism of failure through insights into vessel wall composition, remodeling, and inflammation. Restenosis has a known relationship to inflammation. Advances in micro-catheter technologies offer the ability to deliver anti-inflammatory medications such as Dexamethasone (DEX) directly to the adventitia and advances in drug delivery on balloon surfaces to deliver paclitaxel to the intima of the artery.

This study aims to investigate if patient-specific parameters affect angioplasty outcomes, if DEX has a biological effect on the vessel wall, and if this effect is through the reduction of inflammation.

In response to an FDA issued "Letter to Healthcare Providers" dated August 9, 2019 that reported the "relative risk for increased mortality at 5 years was 1.57 (95% confidence interval 1.16 - 2.13), which corresponds to a 57% relative increase in mortality in patients treated with paclitaxel-coated devices," participant enrollment in the paclitaxel drug coated balloon arm was stopped and a plain balloon angioplasty arm was added to the protocol.

Being tested
Dexamethasone infusion, Drug coated balloon, Plain balloon angioplasty
Keywords
angioplasty, peripheral artery disease, peripheral vascular disease, atherosclerosis, balloon angioplasty, dexamethasone, drug coated balloon, paclitaxel, walking, claudication
Medical subject headings
Peripheral Arterial Disease, Vascular Diseases, Chronic Limb-Threatening Ischemia, Peripheral Vascular Diseases, Atherosclerosis, Intermittent Claudication

What participants receive

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

  • Dexamethasone infusionDrug

    Also called microinfusion catheter

    Participants will receive dexamethasone infusion following plain balloon angioplasty

  • Drug coated balloonDevice

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

  • Plain balloon angioplastyDevice

    Participants will receive plain balloon angioplasty only

Study groups in NCT02807779
Study groupRoleWhat they receive
DexamethasoneExperimentalParticipants randomized to the Dexamethasone group will receive dexamethasone infusion to the adventitia of the artery following plain-old-balloon-angioplasty (POBA).
Receives: Drug: Dexamethasone infusion
Drug Coated BalloonActive comparatorParticipants 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.
Receives: Device: Drug coated balloon
Plain Balloon AngioplastyActive comparatorParticipants randomized to the Plain Balloon Angioplasty will receive balloon angioplasty (POBA) only. They will not receive a dexamethasone infusion to the adventitia or paclitaxel.
Receives: Device: Plain balloon angioplasty

What is being measured

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

  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

    Measured: From Post-Operative Day One to 12 Months

Secondary outcomes (7)

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

    The change in wall volume (WV) without change in total vessel volume (TVV) of the treated segment between the postoperative and 12 month time points as measured by MRI

    Measured: From Post-Operative Day One to 12 Months

  2. Change in Perioperative Inflammatory Profile (MCP-1)

    The serum concentration of monocyte chemoattractant protein-1 (MCP-1) between postprocedure day 1 and 12 months postprocedure. Reported as the area under the curve (AUC) of the MCP-1 concentration (postprocedure day 1, 1 month and 12 months)

    Measured: From Post-Operative Day One to 12 Months

  3. Change in Perioperative Inflammatory Profile (CRP)

    The serum concentration of C-reactive protein (CRP) between postprocedure day 1 and 12 months postprocedure. Reported as the area under the curve (AUC) of the CRP concentration (postprocedure day 1, 1 month and 12 months).

    Measured: From Post-Operative Day One to 12 Months

  4. Change in Perioperative Inflammatory Profile (IL-1beta)

    The serum concentration of interleukin-1beta (IL-1beta) between postprocedure day 1 and 12 months postprocedure. Reported as the area under the curve (AUC) of the IL-1beta concentration (postprocedure day 1, 1 month and 12 months).

    Measured: From Post-Operative Day One to 12 Months

  5. Change in Transfer Constant (Ktrans)

    The change in adventitial transfer constant (Ktrans) of the treated segment between the postoperative and 6 month time points as measured by dynamic contrast enhanced MRI

    Measured: From 1 Month to 6 Months

  6. Change in Lumen Volume (LV) Relative to Total Vessel Volume (TVV)

    The change in lumen volume (LV) relative to total vessel volume (TVV) of the treated segment between the postoperative and 12 month time points as measured by MRI

    Measured: From Post-Operative Day One to 12 Months

  7. Percentage of Subjects With Clinically Significant Restenosis That Undergo Reintervention of Greater Than or Equal to 75% of the Treated Segment

    Percentage of subjects with clinically significant restenosis that undergo reintervention of greater than or equal to 75% of the treated segment by the 12 month timepoint.

    Measured: From Post-Operative Day One to 12 Months

Timeline

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

  1. First posted21 Jun 2016 (estimated)
  2. Study start10 Feb 2016
  3. Primary completion31 Oct 2020
  4. Study completion31 Oct 2022

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02807779
Sponsor's protocol ID
15-17251
Other IDs
1R01HL128816-01
Acronym
INVADER_MRI
Status last verified
Jun 2025
First submitted
1 Apr 2016
Last updated
17 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexamethasone infusion, Drug coated balloon and Plain balloon angioplasty in people with Peripheral Artery Disease and Vascular Disease, run by University of California, San Francisco at 2 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 14 inclusion and 21 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 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Yes. Results are posted in the registry (first posted 17 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Percent Wall Volume (PWV) (time frame: From Post-Operative Day One to 12 Months). 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 NCT02807779.

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 17 Jul 2025.

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