Peripheral Vascular Diseases
Conditions
Keywords
MRI Guided Management of Occlusive Peripheral Arterial Disease, PAD, Peripheral Vascular Disease, PVI, MRI, MRA
Brief summary
The goal of this observational study is to identify which plaque lesions in patients with peripheral arterial disease are impenetrable and to determine which devices minimize vessel wall injury. Patients undergoing intervention will have an MRI scan prior to their planned percutaneous vascular intervention to assess the plaque and predict procedural difficulty. Patients undergoing lower limb amputation due to peripheral arterial disease will have their limbs included into a second arm of the study The limb will undergo an MRI scan to assess the plaque. The investigator will then test two different devices and assess the effects of these devices on the vessel wall.
Detailed description
Please see attached study protocol.
Interventions
None listed
Sponsors
The Methodist Hospital Research Institute
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A. General Inclusion Criteria: i. All patients will be ≥ 18 years old with PAD (Rutherford Category 4, 5, 6) B. Anatomic inclusion criteria: i. At least 1 target lesion below-the-knee in native vessels in one or both limbs ii. Target lesion reference vessel diameter between 2.0 - 4.0 mm by investigator visual estimate iii. Target lesion with \> 50% stenosis by investigator visual estimate
Exclusion criteria
A. General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient primary Outcome | Intraprocedural - the outcome is at the time of the procedure, it is not a follow up outcome. | PVI failure due to inability to cross the target plaque with a guidewire. |
| Amputation Arm Outcome | From Experiment and detected during Histological Evaluation (there is no timeframe from this as it is after the experiment on histological analysis) | Presence of dissections on histology (number of dissections i.e. count, idissection score) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient outcome measures | Intraprocedural | 1. Plaque-crossing time (seconds), 2. successful target lesion revascularization (yes or no) 3. use of adjunct devices beyond plain balloon angioplasty (record name of device\[s\]) 4. injury/dissection of vessel requiring stent (record event title e.g. dissection) 5. plaque embolization (yes/no) 6. number and stiffness of wires and catheters used (record device names) 7. subintimal crossing (yes/no) 8. outcomes after antegrade/retrograde access (successful/unsuccessful) |
| Amputation Arm Outcomes | From Experiment and Histologicla Examination | 1. Minimal inflation pressure 2. mean luminal gain percentage based on IVUS 3. severity of dissections using iDissection classification and 4. endothelial injury |
| Patient Outcome Measure | Intraprocedural | Hypothesis: Women will have less MRI-defined hard lesions and plaques that are easier to cross Comparison Groups: Women vs. Men Primary Outcome: PVI failure due to inability to cross the target plaque with a guidewire (record number of hard lesions i.e. count, comparing men and women) |
Countries
United States
Contacts
CONTACTTrisha Roy, MD, PhD
Outcome results
None listed