CVI Drug Coated Balloon First In Human Trial

NCT ID: NCT02110524

Last Updated: 2015-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2014-12-31

Brief Summary

The purpose of this study is to assess safety and the inhibition of restenosis of the CVI Paclitaxel-coated PTA Balloon Catheter in the treatment of de-novo occluded/stenotic or reoccluded/restenotic superficial femoral (SFA) or popliteal arteries.

The primary endpoint for this analysis is late lumen loss at six (6) months.

Detailed Description

Prospective, controlled, multi-center, open, single arm study

Main cohort: 50; pre-specified treatment group: 30. Total patients: 80

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CVI Drug Coated Balloon

Group Type: EXPERIMENTAL

Percutaneous Transluminal Angioplasty

Intervention Type: DEVICE

Interventions

Percutaneous Transluminal Angioplasty

Intervention Type: DEVICE

Other Intervention Names

CVI Paclitaxel-coated, Percutaneous Transluminal Angioplasty (PTA) Balloon; Catheter

Eligibility Criteria

Inclusion Criteria

• Subjects with symptomatic leg ischemia, requiring treatment of SFA or popliteal (P1 segment) artery
• De novo or restenotic lesion(s) >70% within the SFA and popliteal arteries in a single limb which are ≥3 cm and ≤15 cm in cumulative total length (by visual estimation).
• Target vessel reference diameter ≥3 mm and ≤7 mm (by visual estimation).
• Rutherford classification of 2, 3 or 4

Exclusion Criteria

• Lesion length is <3 cm or >15 cm or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured.
• Outflow arteries (distal popliteal, anterior or posterior tibial or peroneal arteries) with significant lesions (≥ 50% stenosis) may not be treated during the same procedure.
• Treatment of the contralateral limb during the same procedure or within 30 days of the study procedure.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spectranetics Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henrik Schröder, MD

Role: PRINCIPAL_INVESTIGATOR

Jewish Hospital Berlin

Locations

Jewish Hospital Berlin

Berlin, , Germany

Countries

Germany

References

Gray WA, Jaff MR, Parikh SA, Ansel GM, Brodmann M, Krishnan P, Razavi MK, Vermassen F, Zeller T, White R, Ouriel K, Adelman MA, Lyden SP. Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years. Circulation. 2019 Oct;140(14):1145-1155. doi: 10.1161/CIRCULATIONAHA.119.040518. Epub 2019 Sep 30.

Reference Type: DERIVED

PMID: 31567024 (View on PubMed)

Other Identifiers

TP1027

Identifier Type: -

Identifier Source: org_study_id