Clinical trial NCT04600934: Shockwave Assisted Large Bore Access
Official title: Shockwave Assisted Large Bore Access (TAVR, TEVAR, EVAR, FEVAR)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Vascular Diseases
Keywords: Vascular Surgery
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Shockwave Medical, Inc.
First posted: 2020-10-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Annually, 150-200 TAVR with unilateral large bore access and 200 combined TEVAR/EVAR/FEVAR with bilateral large bore access are performed at our institution. Nearly 50 percent of patients fall outside IFU for access vessel size. Adjuncts described include iliac conduit, crack and pave, balloon expandable sheaths, direct aortic puncture, transcaval delivery, alternative access point (i.e axillary, carotid). Each of these adjuncts comes with additional complication potential and by nature of being used less frequently than the standard femoral access makes the procedure more challenging.

The intervention the use of the Shockwave Medical, Inc. Peripheral Lithoplasty® System to achieve large bore access in patients whose vessels fall outside of the IFU suggested dimensions.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Indicated for planned procedure requiring large bore (\>12 French sheath) access
* Mental capacity to provide informed consent
* Iliac access vessel demonstrates \>50% circumferential calcium
* Iliac access vessel demonstrates maximum inner lumen diameter less than IFU for device required
* Iliac access vessel demonstrates maximum outer wall diameter greater than or equal to IFU for device required
* Preoperative CT angiogram, \</= 5mm slices
* Preoperative ABI/TP
* Unsuccessful delivery of large bore sheath without adjunctive intervention

  o Definition of unsuccessful = operator assessment of the following
* Visible distortion of iliac artery calcification under fluoroscopy without forward progress of device
* Adverse forward pressure application by operator
* Failure of device to track with external pressure applied to abdomen
* Patient intolerance of advancement (pain response) in awake patient

Exclusion Criteria:

* Contraindicated for antiplatelet therapy (aspirin or plavix)
* Planned iliofemoral surgical reconstruction in next 30 days
* Prior common or external iliac artery stent placement
* Prior aorto-iliac, aorto-femoral, or iliofemoral bypass present
* Iliac access vessel demonstrates maximum outer wall diameter less than IFU for device required
* Inability to obtain preoperative CTA (contrast allergy, CKD, etc)
* Inability to traverse iliac segment with wire
* Emergent procedure

Primary outcomes:
measure: Successful advancement of planned large bore access device
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Mathew Wooster, MD
role: PRINCIPAL_INVESTIGATOR
References: