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Completed

NCT Number: NCT01804088

FORMAT Clinical Study

The FORMAT Clinical Study is a clinical trial to evaluate the safety and effectiveness of the Formula™ 535 Iliac Balloon-Expandable Stent in treatment of symptomatic vascular disease of the iliac arteries.

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Key information

Conditions

Symptomatic Vascular Disease of the Iliac Arteries Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scripps Health, La Jolla, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Up to two documented common or external iliac artery lesions (one on each side), with >50% diameter stenosis, suitable for stenting
  • iliac artery reference vessel diameter of 5-10 mm
  • Rutherford Category 1, 2, 3, or 4.

Exclusion criteria

  • Less than 18 years of age
  • lesion site <10 or >100 mm in length
  • external iliac artery lesion visually estimated to be 100% occluded
  • presence of infrarenal aortic aneurysm >4 cm (treated or untreated)
  • presence of any aneurysm (treated or untreated) within target vessel
  • significant stenosis (>50%) or occlusion of inflow tract (infrarenal aortic lesions) not successfully treated before this procedure (success is measured as < 30% residual stenosis)
  • absence of at least one patent runoff vessel with ≤ 50% stenosis throughout its course (i.e., confirmed in-line patency to the level of the foot)
  • angiographically evident thrombus within the target vessel (treated or untreated)
  • lesion is in an iliac artery that has been previously stented

Treatment and study plan

Formula™ 535 Iliac Balloon-Expandable Stent

Device

Treatment of symptomatic vascular disease of the iliac arteries

Primary outcomes

  1. Freedom from major adverse events

    Time frame: 9 months

Secondary outcomes

  1. Rate of technical success (i.e., successful delivery and deployment of a Formula™ 535 Iliac Balloon-Expandable Stent)

    Time frame: Intraoperative

  2. Rate of acute procedure success(i.e.,vessel with <30% residual stenosis determined angiographically immediately after stent placement and no major clinical events)

    Time frame: Postoperative until discharge (i.e., 0 to 4 days)

  3. Rate of hemodynamic success(i.e., ABI or TBI improved above baseline)

    Time frame: 30 day, 9 month, 2 year, 3 year

  4. 30-day clinical success (i.e., vessel with <30% residual stenosis determined angiographically immediately after stent placement and no major clinical events)

    Time frame: 30 day

  5. Rate of primary patency (i.e.,the proportion of patients, over time, that have had uninterrupted patency since the initial procedure)

    Time frame: 30 day, 9 month, 2 year, 3 year

  6. Rate of functional status improvement based on walking impairment questionnaire

    Time frame: 30 day, 9 month, 2 year, 3 year

  7. Rate of improvement in Rutherford Category (i.e., improvement above baseline)

    Time frame: 30 day, 9 month, 2 year, 3 year

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

Clinical Investigation of the Cook Formula™ 535 Iliac Balloon-Expandable Stent

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
Mar 5, 2013
Registry last updated
Mar 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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