The Study to Compare the Treatment of Angioplasty and Stents in SFA Occlusions.

NCT00289055 | Terminated Phase 4 DMC

• 1 other identifier: EE04-01NL
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to assess the patency rate of the nitinol self-expandable stent device in the treatment of superficial femoral artery (SFA) occlusions as compared to angioplasty only.

Conditions

Arterial Occlusive Diseases

Keywords

Peripheral Artery Occlusive Disease

Outcome Measures

Primary Outcomes (1)

• Primary patency.

  12 months

Secondary Outcomes (7)

• Technical success defined as a successful access and deployment of the device with recanalization, determined by angiography.

  at deployment

• Procedural success defined as successful recanalization, without the occurrence of a SAE.

  up to the moment haemostasis has been achieved

• Procedural complications, defined as any adverse event

  from start of the procedure up to the moment haemostasis has been achieved

• Ankle Brachial Index.

  discharge and 12 months

• Treadmill test.

  12 months

Study Arms (2)

1

EXPERIMENTAL

Cordis SMART™ Nitinol Stent

Device: stent

2

ACTIVE COMPARATOR

balloon angioplasty

Device: angioplasty

Interventions

stent DEVICE

Cordis SMART™ Nitinol Stent

1

angioplasty DEVICE

balloon angioplasty

2

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3, 4 or 5); duration of intermittent claudication (category 1-3) should be at least 6 months
• The patient should be suitable for percutaneous transluminal angioplasty (PTA) and also for stenting.

You may not qualify if:

• Poor aortoiliac or common femoral "inflow", which would be deemed inadequate to support a femoropopliteal bypass graft.
• Patient having total occlusions or severe stenosis of the iliac artery on the same side must be excluded.
• Gangrene in index limb (Rutherford category 6).

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (1)

AMC

Amsterdam, 1105 AZ, Netherlands

Location

MeSH Terms

Conditions

Arterial Occlusive Diseases; Peripheral Arterial Occlusive Disease 1

Interventions

Stents; Angioplasty

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Jim Reekers, MD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 7, 2006
• First Posted: February 9, 2006
• Study Start: November 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: February 24, 2009

Record last verified: 2009-02

Locations

NL (1)