Chronic Total Occlusion
Conditions
Brief summary
Study of the BridgePoint Medical System in the crossing of chronic total occlusions of the lower extremities.
Interventions
DEVICECTO Crossing and Percutaneous transluminal angioplasty
Crossing of the CTO with the BridgePoint Medical System and subsequent treatment of the CTO via PTA (specific devices to be used for PTA at investigators' discretion)
Sponsors
BridgePoint Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* suitable candidate for non-emergent, peripheral angioplasty * documented de-novo or restenotic peripheral CTO lesion with TIMI 0 flow for at least 90 days and satisfactory distal vessel visualization (collateral supply) * limb ischemia or claudication, Rutherford class I-III (grade 1-5) caused by the occluded artery
Exclusion criteria
* intolerance to aspirin or a neutropenic response to Ticlopidine or Clopidogrel * appearance of thrombus or intraluminal filling defects * peripheral intervention in the target limb within two weeks of the procedure * renal insufficiency (serum creatinine of \> 2.3 mg/dl) * contraindication to a peripheral artery intervention * participation in another investigational protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Patients with a Major Adverse Events (MAE) | 30 Day | MAE is defined as death, major unplanned amputation, perforation requiring intervention, or target lesion revascularization due to complication. |
| Incidence of Intraprocedural Technical Success | Intraprocedural (<24 hours) | Technical success is defined as the placement of a guidewire in the true lumen distal to the CTO |
Countries
United States
Outcome results
None listed