CVI Drug Coated Balloon First In Human Trial | NCT02110524

Studies
CVI Drug Coated Balloon First In Human Trial

NCT02110524

Sponsor

Spectranetics Corporation

Status

Completed

Last Update Posted

Feb 26, 2015Estimated

Enrollment

80Actual

Phase

Not Applicable

Conditions

Peripheral Arterial Disease

Interventions

Percutaneous Transluminal Angioplasty

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Sep 2012Actual

Completion Date

Dec 2014Actual

First Submitted Date

Apr 4, 2014

First Submission Date that Met QC Criteria

Apr 8, 2014

First Posted Date

Apr 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2015

Last Update Posted Date

Feb 26, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CVI Drug Coated Balloon	Experimental		Device: Percutaneous Transluminal Angioplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Percutaneous Transluminal Angioplasty	Device		CVI Drug Coated Balloon	CVI Paclitaxel-coated, Percutaneous Transluminal Angioplasty (PTA) Balloon

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary endpoint: Angiographic late lumen loss	difference between minimum lumen diameter after intervention and follow up.	6Month

Secondary Outcomes

Measure	Description	Time Frame
Secondary safety endpoint: Major Adverse Event (MAE) rate	composite rate of cardiovascular death, index limb amputation and ischemia driven target lesion revascularization (TLR).	6Months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henrik Schröder, MD	Jewish Hospital Berlin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jewish Hospital Berlin		Berlin		13347	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31567024	Derived	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.

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

ID	Term
D017130	Angioplasty
D057785	Catheters

ID	Term
D002404	Catheterization
D013812	Therapeutics
D057510	Endovascular Procedures
D014656	Vascular Surgical Procedures