Phase 4
N=20
Intima Versus Adventitia Drug Delivery to Elucidate Mechanisms of Restenosis: Magnetic Resonance Imaging
Peripheral Artery Disease · Vascular Disease · Critical Limb Ischemia
Bottom Line
View on ClinicalTrials.gov: NCT02807779 ↗Enrolled (actual)
20
Serious AEs
75.0%
Results posted
Jul 2025
Primary outcome: Primary: Change in Percent Wall Volume (PWV) — 12.3; 3.9 Percent Wall Volume — p=0.22
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexamethasone infusion (Drug); Drug coated balloon (Device); Plain balloon angioplasty (Device)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percent Wall Volume (PWV) |
12.3; 3.9 | 0.22 |
| SECONDARY Change in Wall Volume (WV) Without a Change in Total Vessel Volume (TVV) |
28.7; 4.5 | 0.64 |
| SECONDARY Change in Perioperative Inflammatory Profile (MCP-1) |
27933; 277745 | 0.95 |
| SECONDARY Change in Perioperative Inflammatory Profile (CRP) |
1721; 1863 | 0.88 |
| SECONDARY Change in Perioperative Inflammatory Profile (IL-1beta) |
— | — |
| SECONDARY Change in Transfer Constant (Ktrans) |
-0.0002; -0.0067 | .055 |
| SECONDARY Change in Lumen Volume (LV) Relative to Total Vessel Volume (TVV) |
-12.3; -3.88 | .22 |
| SECONDARY Percentage of Subjects With Clinically Significant Restenosis That Undergo Reintervention of Greater Than or Equal to 75% of the Treated Segment |
4; 4; 1 | 0.81 |
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.
Eligibility Criteria
Inclusion Criteria
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
Exclusion Criteria
Screening Criteria:
- Any contraindication to receiving an MRI
- Pregnant, nursing, or planning on becoming pregnant in 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.
Data sourced from ClinicalTrials.gov (NCT02807779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.