Trial Outcomes & Findings for The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study (NCT NCT00753337)

NCT ID: NCT00753337

Last Updated: 2016-04-04

Results Overview

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 Subjects are considered unevaluable for MAE to 9 months if a) withdrawn before 240 days without having MAE events or b) lost to follow-up before 240 days without having MAE events and had no contact thereafter or c) any device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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 123 participants
• Primary outcome timeframe: 9 months
• Results posted on: 2016-04-04

Participant Flow

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

Participant milestones

Measure	Assurant Cobalt Iliac Stent Cobalt stent implanted using standard percutaneous intervention technique.
Overall Study STARTED	123
Overall Study COMPLETED	123
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Assurant Cobalt Iliac Stent n=123 Participants Treatment with iliac stenting
Age, Continuous Age	65.5 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants
Sex: Female, Male Male	69 Participants n=5 Participants
Region of Enrollment United States	123 participants n=5 Participants

PRIMARY outcome

Timeframe: 9 months

Population: Intent to Treat population (ITT)

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 Subjects are considered unevaluable for MAE to 9 months if a) withdrawn before 240 days without having MAE events or b) lost to follow-up before 240 days without having MAE events and had no contact thereafter or c) any device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.

Outcome measures

Measure	Assurant Cobalt Iliac Stent n=123 Participants Treatment with iliac stenting
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 Interval 0.0 to 4.5

SECONDARY outcome

Timeframe: 9 months

Population: Intent to Treat population

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.

Outcome measures

Measure	Assurant Cobalt Iliac Stent n=141 Lesions Treatment with iliac stenting
Primary Patency Rate at 9 Months	100 percentage of lesions

SECONDARY outcome

Timeframe: 9 months

Population: Intent to Treat population

Device Success defined as angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.

Outcome measures

Measure	Assurant Cobalt Iliac Stent n=159 Lesion Treatment with iliac stenting
Device Success	97.5 percentage of lesions Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 9 months

Population: Intent to Treat population

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.

Outcome measures

Measure	Assurant Cobalt Iliac Stent n=159 Lesions Treatment with iliac stenting
Lesion Success	97.5 percentage of lesions

SECONDARY outcome

Timeframe: 9 months

Population: Intent to Treat population

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)

Outcome measures

Measure	Assurant Cobalt Iliac Stent n=123 Participants Treatment with iliac stenting
Procedure Success	96.7 percentage of participants

SECONDARY outcome

Timeframe: 30 days

Population: Intent to Treat population

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.

Outcome measures

Measure	Assurant Cobalt Iliac Stent n=152 Limbs Treatment with iliac stenting
Clinical Success	88.2 percentage of limbs

SECONDARY outcome

Timeframe: 9 months

Population: Intent to Treat population

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.

Outcome measures

Measure	Assurant Cobalt Iliac Stent n=146 Limbs Treatment with iliac stenting
Clinical Success	90.4 percentage of limbs Interval 84.4 to 94.7

SECONDARY outcome

Timeframe: 30 days

Population: Intent to Treat population

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.

Outcome measures

Measure	Assurant Cobalt Iliac Stent n=153 Limbs Treatment with iliac stenting
Hemodynamic Success	64.1 percentage of limbs

SECONDARY outcome

Timeframe: 9 months

Population: Intent to Treat population

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.

Outcome measures

Measure	Assurant Cobalt Iliac Stent n=143 Limbs Treatment with iliac stenting
Hemodynamic Success	55.2 percentage of limbs

SECONDARY outcome

Timeframe: 30 days

Population: Intent to Treat population

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.

Outcome measures

Measure	Assurant Cobalt Iliac Stent n=123 Participants Treatment with iliac stenting
All Cause Mortality	0.0 participants

SECONDARY outcome

Timeframe: 9 months

Population: Intent to Treat population

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.

Outcome measures

Measure	Assurant Cobalt Iliac Stent n=121 Participants Treatment with iliac stenting
All Cause Mortality	0.0 participants Interval 0.0 to 3.0

Adverse Events

Assurant Cobalt Iliac Stent

Serious events: 37 serious events

Other events: 78 other events

Deaths: 0 deaths

Serious adverse events

Measure	Assurant Cobalt Iliac Stent n=123 participants at risk Treatment with Iliac stenting system
Vascular disorders GASTROINTESTINAL DISORDERS	1.6% 2/123 • Number of events 2 • From subject index procedure through the 9 month follow up visit period.
Cardiac disorders CARDIAC DISORDERS	11.4% 14/123 • Number of events 14 • From subject index procedure through the 9 month follow up visit period.
General disorders GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	2.4% 3/123 • Number of events 3 • From subject index procedure through the 9 month follow up visit period.
Hepatobiliary disorders HEPATOBILIARY DISORDERS	0.81% 1/123 • Number of events 1 • From subject index procedure through the 9 month follow up visit period.
Infections and infestations INFECTIONS AND INFESTATIONS	6.5% 8/123 • Number of events 8 • From subject index procedure through the 9 month follow up visit period.
Injury, poisoning and procedural complications INJURY, POISONING AND PROCEDURAL COMPLICATIONS	4.1% 5/123 • Number of events 5 • From subject index procedure through the 9 month follow up visit period.
Investigations INVESTIGATIONS	0.81% 1/123 • Number of events 1 • From subject index procedure through the 9 month follow up visit period.
Metabolism and nutrition disorders METABOLISM AND NUTRITION DISORDERS	0.81% 1/123 • Number of events 1 • From subject index procedure through the 9 month follow up visit period.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	4.1% 5/123 • Number of events 5 • From subject index procedure through the 9 month follow up visit period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)	0.81% 1/123 • Number of events 1 • From subject index procedure through the 9 month follow up visit period.
Nervous system disorders NERVOUS SYSTEM DISORDERS	0.81% 1/123 • Number of events 1 • From subject index procedure through the 9 month follow up visit period.
Renal and urinary disorders RENAL AND URINARY DISORDERS	2.4% 3/123 • Number of events 3 • From subject index procedure through the 9 month follow up visit period.
Reproductive system and breast disorders REPRODUCTIVE SYSTEM AND BREAST DISORDERS	0.81% 1/123 • Number of events 1 • From subject index procedure through the 9 month follow up visit period.
Respiratory, thoracic and mediastinal disorders RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	1.6% 2/123 • Number of events 2 • From subject index procedure through the 9 month follow up visit period.
Vascular disorders VASCULAR DISORDERS	12.2% 15/123 • Number of events 15 • From subject index procedure through the 9 month follow up visit period.

Other adverse events

Measure	Assurant Cobalt Iliac Stent n=123 participants at risk Treatment with Iliac stenting system
Vascular disorders CARDIAC DISORDERS	16.3% 20/123 • Number of events 20 • From subject index procedure through the 9 month follow up visit period.
Gastrointestinal disorders GASTROINTESTINAL DISORDERS	11.4% 14/123 • Number of events 14 • From subject index procedure through the 9 month follow up visit period.
General disorders GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS	13.8% 17/123 • Number of events 17 • From subject index procedure through the 9 month follow up visit period.
Infections and infestations INFECTIONS AND INFESTATIONS	13.8% 17/123 • Number of events 17 • From subject index procedure through the 9 month follow up visit period.
Injury, poisoning and procedural complications INJURY, POISONING AND PROCEDURAL COMPLICATIONS	11.4% 14/123 • Number of events 14 • From subject index procedure through the 9 month follow up visit period.
Metabolism and nutrition disorders METABOLISM AND NUTRITION DISORDERS	6.5% 8/123 • Number of events 8 • From subject index procedure through the 9 month follow up visit period.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS	17.9% 22/123 • Number of events 22 • From subject index procedure through the 9 month follow up visit period.
Nervous system disorders NERVOUS SYSTEM DISORDERS	6.5% 8/123 • Number of events 8 • From subject index procedure through the 9 month follow up visit period.
Renal and urinary disorders RENAL AND URINARY DISORDERS	7.3% 9/123 • Number of events 9 • From subject index procedure through the 9 month follow up visit period.
Respiratory, thoracic and mediastinal disorders RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS	8.9% 11/123 • Number of events 11 • From subject index procedure through the 9 month follow up visit period.
Skin and subcutaneous tissue disorders SKIN AND SUBCUTANEOUS TISSUE DISORDERS	7.3% 9/123 • Number of events 9 • From subject index procedure through the 9 month follow up visit period.
Vascular disorders VASCULAR DISORDERS	26.0% 32/123 • Number of events 32 • From subject index procedure through the 9 month follow up visit period.

Additional Information

Arslan Malik - Senior Clinical Research Manager

Medtronic Aortic and Peripheral Vascular

Phone: (707) 541-3256

Email: arslan.malik@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee Medtronic has a legitimate interest in ensuring that a multi-center publication is the first publication to be released regarding the completed Study. The Institution agrees that it will not publish or disclose any results of or information pertaining to the study until a multi-center publication is released. If a publication is not released within one year after completion of the study, the Institution will have the right to publish information pertaining to their activities conducted.
• Publication restrictions are in place

Restriction type: OTHER