Trial Outcomes & Findings for The Complete® Self-Expanding Stent and Stent Delivery System Registry (NCT NCT00730730)

Last Updated: 2016-04-04

Results Overview

Major adverse events (MAE) defined as any death, target limb loss or clinically-driven Target Lesion Revascularization (TLR)/Target Vessel Revascularization (TVR) with percutaneous transluminal angioplasty or aorto-iliac bypass graft) for all subjects enrolled into the registry

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

30 days

Results posted on

2016-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	Complete SE Iliac Stent Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Complete® Self-Expanding Stent and Stent Delivery System Registry

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Iliac Stenting n=50 Participants Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
Age, Continuous	66 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Intent-to-treat population (ITT)

Outcome measures

Outcome measures
Measure	Complete SE Iliac Stent n=50 Participants Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
The Number of Participants With Major Adverse Events (MAE)	0 participants

SECONDARY outcome

Timeframe: from after stent placement to prior to hospital discharge (up to 3 days)

Population: Intent to Treat population(ITT); missing angiographic data for one patient

angiographic evidence of \< 30 % final residual stenosis of the target lesion after stent placement with no occurrence of a device- related, procedure-related MAE or vascular event (stent thrombosis, major bleeding complications)

Outcome measures

Outcome measures
Measure	Complete SE Iliac Stent n=49 Participants Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
Number of Participants With Acute Success	44 participants

SECONDARY outcome

Timeframe: From baseline up to 30-days

Population: Analysis calculated using number of evaluable limbs with Rutherford results; data missing for two limbs

Improvement of Rutherford scale by ≥ 1 category between pre-procedure (Baseline) and 30-day follow-up- * Category 0: Asymptomatic, no hemodynamically significant occlusive disease; * Category 1: Mild claudication; * Category 2: Moderate claudication; * Category 3: Severe claudication; * Category 4: Ischemic rest pain; * Category 5: Minor tissue loss; non-healing ulcer; focal gangrene with diffuse pedal ischemia; * Category 6: Major tissue loss extending above transmetatarsal level;functional foot no longer salvageable

Outcome measures

Outcome measures
Measure	Complete SE Iliac Stent n=54 limbs Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
Number of Limbs With Improvement Using Rutherford Scale to Determine Clinical Success.	46 limbs

SECONDARY outcome

Timeframe: From baseline up to 30-days

Population: Evaluable Ankle-brachial Index (ABI)/Toe brachial Index (TBI)result: missing data for 1 limb

Improvement in ankle-brachial index (ABI) or toe-brachial index (TBI) \> 0.10 over pre-procedure level OR deterioration by ≤ 0.15 from first post-procedure exam OR pulse volume recording (PVR) distal to the target lesion treated maintained at ≥ 5 mm above pre-procedure tracing for those subjects with no pre-procedure ABI/TBI. An ABI ≥ 0.90 is considered normal.

Outcome measures

Outcome measures
Measure	Complete SE Iliac Stent n=55 limbs Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
Number of Limbs With Improvement Using Ankle-brachial Index and Toe Brachial Index to Determine Hemodynamic Success.	55 limbs Interval 93.5 to 100.0

Adverse Events

Iliac Stenting

Serious events: 5 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Iliac Stenting n=50 participants at risk Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
Renal and urinary disorders Acute Renal Failure	2.0% 1/50 • Number of events 1 • 30 days
Cardiac disorders Congestive Heart Failure	2.0% 1/50 • Number of events 1 • 30 days
Cardiac disorders Coronary Artery Disease	2.0% 1/50 • Number of events 1 • 30 days
Vascular disorders Dissection - Target Vessel	2.0% 1/50 • Number of events 1 • 30 days
Cardiac disorders NSTEMI - Acute	2.0% 1/50 • Number of events 1 • 30 days
Injury, poisoning and procedural complications Pseudoaneurysm Left Femoral Artery	2.0% 1/50 • Number of events 1 • 30 days
Respiratory, thoracic and mediastinal disorders Respiratory Failure	2.0% 1/50 • Number of events 1 • 30 days
Gastrointestinal disorders Retroperitoneal Bleed	2.0% 1/50 • Number of events 1 • 30 days
Vascular disorders Right Lower Extremity Gangrene	2.0% 1/50 • Number of events 1 • 30 days
Vascular disorders Right Toe Gangrene	2.0% 1/50 • Number of events 1 • 30 days
Hepatobiliary disorders Shock Liver	2.0% 1/50 • Number of events 1 • 30 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small Cell Lung Cancer	2.0% 1/50 • Number of events 1 • 30 days
Cardiac disorders Ventricular Tachycardia	2.0% 1/50 • Number of events 1 • 30 days

Other adverse events

Other adverse events
Measure	Iliac Stenting n=50 participants at risk Iliac stenting (Complete® Self-Expanding Stent) for the treatment of de novo and restenotic lesions in iliac arteries in subjects with peripheral vascular disease (PVD)
Musculoskeletal and connective tissue disorders Back Pain	8.0% 4/50 • Number of events 4 • 30 days

Additional Information

Arslan Malik - Senior Clinical Research Manager

Medtronic Aortic and Peripheral Vascular

Phone: (707) 541-3256

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigator/Institution agree to submit to Sponsor copies of any proposed publication/public presentation ("Proposed Publication") at least sixty (60) calendar days in advance of dissemination. Sponsor will review/comment within thirty (30) calendar days after receipt thereof. If Sponsor objects to dissemination of any part of the Proposed Publication, Investigator, and Institution shall refrain from disseminating or presenting such Proposed Publication until Sponsor is satisfied.
Publication restrictions are in place

Restriction type: OTHER