The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study

The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study Using the Medtronic Assurant Cobalt Iliac Balloon-Expandable Stent System

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00753337

Acronym

ACTIVE

Enrollment

123

Registered

2008-09-16

Start date

2008-10-31

Completion date

2013-09-30

Last updated

2016-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Vascular Disease

Brief summary

The objective of this study is to evaluate the safety and efficacy of the Assurant Cobalt Iliac Stent System in the treatment of de novo and restenotic lesions in iliac arteries of subjects with Peripheral Artery Disease (PAD).

Detailed description

This study is being conducted to collect 9 month safety and efficacy data on the Assurant Cobalt Iliac Stent for all subjects enrolled into the study.

Interventions

DEVICEAssurant® Cobalt Iliac Stent System

Iliac Stenting

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* The lesion(s) is either de novo or restenotic in nature, located in the common iliac artery and/or the external iliac artery; * The subject is symptomatic (Fontaine stage II or III) with a target lesion stenosis ≥ 50% . * The target vessel(s) reference diameter is ≥ 6 mm and ≤ 10 mm by visual estimate; * The lesion length is \< 100 mm (10 cm)

Exclusion criteria

* Excessive peripheral vascular disease(PVD), unresolved fresh thrombus or tortuousity,or heavily calcified. * Tissue loss in the target extremities. * The target lesion is in a prosthetic vascular bypass graft or within 1 cm of a graft anastomosis; * The target lesion is in an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion. * The lesion requires treatment other than percutaneous transluminal angioplasty (PTA) prior to stent placement; * Other lesions requiring treatment or surgery within 30 days of the procedure (pre or post) with the exception of the non-target lesion(s). * Inadequate distal run-off. * History of bleeding diatheses or coagulopathy or will refuse blood transfusions; * Creatinine \> 2.5 mg/dl * Platelet count \<80,000 cells/mm3 or \>700,000 cells/mm3, or a white blood cell (WBC) of \<3,000 cells/mm3 * Participation in another investigational device or drug study and has not completed the primary endpoint(s) or that clinically interferes with the study endpoints; * Previously enrolled in the Study.

Design outcomes

Primary

Measure	Time frame	Description
Major Adverse Events (MAE), Measured as Device and/or Procedure Related Death, Target Limb Loss and/or Clinically Driven Target Lesion Revascularization (TLR) or Target Vessel Revascularization (TVR).	9 months	Percentage based on number of evaluable subjects for MAE. Subjects are considered unevaluable for MAE to 9 months if a) withdrawn before 240 days without having MAE events or b) lost to follow-up before 240 days without having MAE events and had no contact thereafter or c) any device and/or procedure-unrelated death before 240 days without having MAE events.

Secondary

Measure	Time frame	Description
Device Success	9 months	Device Success defined as angiographic evidence of \<30% final residual stenosis of the target lesion using only the assigned device.
Lesion Success	9 months	Lesion Success defined as angiographic evidence of \<30% final residual stenosis of the target lesion using any percutaneous method such as baloon angioplasy or other stent.
Procedure Success	9 months	Procedure Success defined as angiographic evidence of \<30% final residual stenosis of the target lesion after stent placement and no occurrence of a procedure related MAE prior to hospital discharge (for subjects with more than one lesion stented the worse case is counted)
Primary Patency Rate at 9 Months	9 months	Primary patency was defined as the blood flow through the treated vessel segment into the distal vasculature (e.g. the common femoral artery and/or the deep femoral artery) as evidenced by duplex ultrasound scan at 9 months for all subjects enrolled with evaluable duplex scans.
Hemodynamic Success	30 days	Hemodynamic success defined as an improvement in ankle-brachial Index (ABI) or toe brachial index (TBI) \> 0.10 over pre-procedure level and not deteriorated by \> 0.15 from first post-procedure level.
All Cause Mortality	30 days	Subjects are considered unevaluable for all cause mortality at 30 days if a) withdrawn before 25 days or b) lost to follow-up before 25 days and had no contact thereafter.
Clinical Success	30 days	Clinical success defined as the improvement of Fontaine classification by at least one stage above the pretreated (pre-procedure) clinical value. The reported values are a percentage of limbs showing improvement.

Countries

United States

Participant flow

Recruitment details

Recruitment was for a period of 16 months. Subjects were recruited at medical clinics who participate in clinical trials.

Participants by arm

Arm	Count
Assurant Cobalt Iliac Stent Treatment with iliac stenting	123
Total	123

Baseline characteristics

Characteristic	Assurant Cobalt Iliac Stent
Age, Continuous Age	65.5 years STANDARD_DEVIATION 10.6
Region of Enrollment United States	123 participants
Sex: Female, Male Female	54 Participants
Sex: Female, Male Male	69 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	78 / 123
serious Total, serious adverse events	37 / 123

Outcome results

Primary

Major Adverse Events (MAE), Measured as Device and/or Procedure Related Death, Target Limb Loss and/or Clinically Driven Target Lesion Revascularization (TLR) or Target Vessel Revascularization (TVR).

Percentage based on number of evaluable subjects for MAE. Subjects are considered unevaluable for MAE to 9 months if a) withdrawn before 240 days without having MAE events or b) lost to follow-up before 240 days without having MAE events and had no contact thereafter or c) any device and/or procedure-unrelated death before 240 days without having MAE events.

Time frame: 9 months

Population: Intent to Treat population (ITT)

Arm	Measure	Value (NUMBER)
Assurant Cobalt Iliac Stent	Major Adverse Events (MAE), Measured as Device and/or Procedure Related Death, Target Limb Loss and/or Clinically Driven Target Lesion Revascularization (TLR) or Target Vessel Revascularization (TVR).	0.8 percentage of participants

Secondary

All Cause Mortality

Subjects are considered unevaluable for all cause mortality at 9 months if a) withdrawn before 240 days or b) lost to follow-up before 240 days and had no contact thereafter.

Time frame: 9 months