Photoablative Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis in Instent Femoro-popliteal Obstructions — PHOTOPAC  

Restenosis Clinical Trial

Official title: Photoablative Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis in Instent Femoro-popliteal Obstructions

Status Enrolling by invitation

Clinical Trial Summary

The objective of this study is to evaluate the safety and efficacy of preparing a vessel with photoablation with Spectranetics CVX-300® Excimer laser and laser catheters prior to local Paclitaxel delivery compared to local Paclitaxel delivery without initial photoablation

Clinical Trial Description

This is a prospective, two-arm randomized study. The control cohort (PTX PTA group, Admiral Inpact or Pacific Inpact, Medtronic-Invatec) will be treated with a PTX-coated PTA balloon. The experimental cohort (Laser+PTX PTA group) will be treated with photoablative atherectomy followed by a PTX-coated PTA balloon. Subjects meeting the definitions of Rutherford Clinical Categories 1 to 5 with instent lesions located in superficial femoral artery and the popliteal artery above the knee joint are eligible for enrollment.

The purpose of this feasibility study is to evaluate the safety and effectiveness of preparing an instent lesion with photoablative atherectomy prior to local Paclitaxel delivery compared to local Paclitaxel delivery without initial photoablative atherectomy.

Primary Outcome:

Target Lesion Percent Diameter Stenosis (%DS) at 1 Year defined as the narrowest point of the target lesion divided by the estimated native vessel diameter at that location as determined by the ACL.

Secondary Outcomes:

The following secondary outcomes will be summarized in this study.

1. Procedural Success: Defined as ≤ 30% residual stenosis following the procedure at the target lesion, without periprocedural complications, as determined by the ACL.

2. Major Adverse Event Rate at 30 Days and 1 Year: Defined as major unplanned amputation of the treated limb, all-cause mortality within 1 year of the index procedure or clinically-driven target vessel revascularization within 30 days of the index procedure.

3. Improvement in WIQ Score at 6 Months and 1 Year: Defined as an increase in Walking Impairment Questionnaire (WIQ) score at 6 months and 1 year compared to baseline.

4. Improvement in EQ-5D Score at 6 Months and 1 Year: Defined as an increase in the EQ-5D questionnaire score at 6 months and 1 year compared to baseline.

5. Improvement in Rutherford Clinical Category at 6 Months and 1 Year: Defined as an improvement in clinical status indicated by a decrease of one or more in Rutherford Clinical Category at 6 months and 1 year compared to baseline, that is attributable to the target limb (in cases of bilateral disease).

6. Improvement in Ankle-Brachial Index at 6 Months and 1 Year: Defined as an increase in the ankle-brachial index (ABI) at 6 months and 1 year compared to baseline in subjects with compressible arteries and baseline ABI < 0.9.

7. Clinically-Driven Target Lesion Revascularization (TLR) at 6 Months and 1 Year. Defined as any reintervention or artery bypass graft surgery involving the target lesion in which the subject has ≥ 50% diameter stenosis in the presence of recurrent symptoms (i.e. claudication) or ≥ 70% stenosis without any symptoms (i.e. decreased ABI).

8. Patency Rate (Peak Systolic Velocity ≤ 3.5) at 6 & 12 Months: Defined by duplex ultrasound core lab measurement of peak systolic velocity (PSV) ratio ≤ 3.5 at the target lesion with no clinically-driven reintervention within the target lesion.

9. Alternative Patency Rate (Peak Systolic Velocity ≤ 2.4) at 6 & 12 Months: Defined by duplex ultrasound core lab measurement of peak systolic velocity (PSV) ratio ≤ 2.4 at the target lesion with no clinically-driven reintervention within the target lesion.

10. Minimum Lumen Diameter at 1 Year: Determined by angiographic assessment of the target lesion at 1 year by the ACL.

11. Net Lumen Gain at 1 Year: Defined as the difference between the target lesion MLD at baseline and 1 year following the index procedure per angiographic assessment determined by the ACL.

12. Patency Rate at 1 Year: Defined as ≤ 70% stenosis per angiography as determined by the ACL.

13. Secondary Patency Rate at 1 Year: Defined as ≤ 70% stenosis per angiography as determined by the ACL, maintained by repeat percutaneous intervention. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Restenosis

• NCT number: NCT01298947
• Study type: Interventional
• Source: Herz-Zentrums Bad Krozingen
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 2011
• Completion date: April 2013