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MRI Guided Management of Occlusive Peripheral Arterial Disease

ConditionPeripheral Vascular Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Methodist Hospital Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

For Revascularization Arm: Patients will be enrolled from Vascular surgical Care at Houston Methodist Hospital and undergoing lower limb PVI. For Amputation Arm: Patients undergoing Major lower limb amputation at Houston Methodist Hospital with PAD.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

175 Participants
are grouped into 2 trial groups
Group A: Amputation Arm
Group B: Revascularization Arm

Trial outcomes

Primary outcomes

1

Patient primary Outcome

PVI failure due to inability to cross the target plaque with a guidewire.

Time frame
Intraprocedural - the outcome is at the time of the procedure, it is not a follow up outcome.
2

Amputation Arm Outcome

Presence of dissections on histology (number of dissections i.e. count, idissection score)

Time frame
From Experiment and detected during Histological Evaluation (there is no timeframe from this as it is after the experiment on histological analysis)

Secondary outcomes

1

Patient outcome measures

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)

Time frame
Intraprocedural
2

Amputation Arm Outcomes

1. Minimal inflation pressure 2. mean luminal gain percentage based on IVUS 3. severity of dissections using iDissection classification and 4. endothelial injury

Time frame
From Experiment and Histologicla Examination
3

Patient Outcome Measure

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)

Time frame
Intraprocedural

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Methodist Hospital Research Institute

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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