CVI Drug Coated Balloon First In Human Trial

Peripheral Arterial Disease Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02110524
• Other study ID #: TP1027
• Status: Completed
• Phase: N/A
• First received: April 4, 2014
• Last updated: February 25, 2015
• Start date: December 2011
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Spectranetics Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Description:

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2014
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Percutaneous Transluminal Angioplasty

Locations

Country	Name	City	State
Germany	Jewish Hospital Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Spectranetics Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint: Angiographic late lumen loss	difference between minimum lumen diameter after intervention and follow up.	6Month	Yes
Secondary	Secondary safety endpoint: Major Adverse Event (MAE) rate	composite rate of cardiovascular death, index limb amputation and ischemia driven target lesion revascularization (TLR).	6Months	No