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CVI Drug Coated Balloon First In Human Trial

Primary Purpose

Peripheral Arterial Disease

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Percutaneous Transluminal Angioplasty

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral Arterial Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Jewish Hospital Berlin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CVI Drug Coated Balloon

Arm Description

Outcomes

Primary Outcome Measures

Primary endpoint: Angiographic late lumen loss

difference between minimum lumen diameter after intervention and follow up.

Secondary Outcome Measures

Secondary safety endpoint: Major Adverse Event (MAE) rate

composite rate of cardiovascular death, index limb amputation and ischemia driven target lesion revascularization (TLR).

Full Information

NCT ID

NCT02110524

First Posted

April 4, 2014

Last Updated

February 25, 2015

Sponsor

Spectranetics Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02110524

Brief Title

CVI Drug Coated Balloon First In Human Trial

Official Title

Prospective, Controlled, Multi-Center, Open, Single Arm Study for the Treatment of Subjects Presenting De Novo Occluded/Stenotic or Re-occluded/Restenotic Lesions of the Superficial Femoral or Popliteal Arteries Using a Paclitaxel-Coated Percutaneous Angioplasty Catheter

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Spectranetics Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CVI Drug Coated Balloon

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Percutaneous Transluminal Angioplasty

Other Intervention Name(s)

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

Primary Outcome Measure Information:

Title

Primary endpoint: Angiographic late lumen loss

Description

difference between minimum lumen diameter after intervention and follow up.

Time Frame

6Month

Secondary Outcome Measure Information:

Title

Secondary safety endpoint: Major Adverse Event (MAE) rate

Description

composite rate of cardiovascular death, index limb amputation and ischemia driven target lesion revascularization (TLR).

Time Frame

6Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henrik Schröder, MD

Organizational Affiliation

Jewish Hospital Berlin

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jewish Hospital Berlin

City

Berlin

ZIP/Postal Code

13347

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

31567024

Citation

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.

Results Reference

derived

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CVI Drug Coated Balloon First In Human Trial

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