N/A N=300 Randomized Single-blind Treatment

Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon

Peripheral Arterial Disease

Bottom Line

View on ClinicalTrials.gov: NCT01858428 ↗

Enrolled (actual)

300

Serious AEs

61.0%

Results posted

Jan 2018

Primary outcome: Primary: Patency at 12 Month Post-procedure — 53; 135 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (Device); EverCross Percutaneous Transluminal Balloon Catheter (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Spectranetics Corporation
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Patency at 12 Month Post-procedure	53; 135	—
PRIMARY Freedom From Device and Procedure-related Death and Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization	79; 174	—
SECONDARY Major Adverse Event (MAE) Rate in the Hospital and at 1, 6, 12, 24, 36, 48 and 60 Months Post-procedure	17; 18	—
SECONDARY Rate of Vascular Access and Bleeding Complications	3; 8	—
SECONDARY Rate of Clinically-driven Target Lesion Revascularization	15; 16	—
SECONDARY Rate of Target Lesion Revascularization	17; 18	—
SECONDARY Rate of Target Limb Major Amputation	0; 0	—
SECONDARY Mortality Rate	2; 5	—
SECONDARY Rate of Occurrence of Arterial Thrombosis of the Treated Segment	0; 2	—
SECONDARY Patency Rate and Freedom From Clinically-driven TLR	58; 133	—
SECONDARY Lesion Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%	98; 196	—
SECONDARY Technical Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%	98; 196	—
SECONDARY Per Subject Clinical Success Achieving no Major Adverse Events During the Procedure	98; 196	—
SECONDARY Per Subject Procedural Success Achieving no Major Adverse Events During the Procedure	98; 196	—
SECONDARY Change in Ankle-brachial Index (ABI) From Pre-procedure	69; 132	—

Summary

This study is designed to evaluate the safety and efficacy of a Paclitaxel-coated percutaneous transluminal angioplasty (PTA) Catheter in the treatment of patients with peripheral arterial disease.

Eligibility Criteria

Inclusion Criteria

Subjects with symptomatic leg ischemia, requiring treatment of the Superficial Femoral Artery (SFA) or popliteal artery.

Exclusion Criteria

Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01858428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.