Paximusâ„¢ Randomized Controlled Trial

Not Applicable

Not yet recruiting

• Conditions: Peripheral vascular disease, unspecified,

• Registration Number: CTRI/2019/05/018886
• Lead Sponsor: Meril Life Sciences Pvt Ltd

Brief Summary

This is a prospective, multicenter, open label, randomized controlled trial to evaluate safety and performance of Paximusâ„¢ (Paclitaxel Eluting Percutaneous Transluminal Angioplasty Balloon Catheter) versus Mozecâ„¢ PTA Balloon Catheter for treatment of blocked or narrowed below the knee arteries in approximately 280 patients

The objective of the study is to compare safety and performance of Paximusâ„¢ with a Mozecâ„¢ PTA balloon for treatment of blocked or narrowed below the knee arteries and to evaluate in-human pharmacokinetics (PK) of the drug in Paximusâ„¢.  All patients will be approached to sign Informed Consent Form approved by respective Ethics Committee before starting the study related process.

After screening for eligibility, patients found eligible for this study will be randomly assigned to either paclitaxel-based drug-eluting balloon (DEB) angioplasty or standard balloon angioplasty in 1:1 ratio using computer - generated randomization system.

30% of the patients will be considered for LLL analysis based on patients’ consent.

14 patients will be considered for PK analysis.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-04-30
• Study Start: 2019-07-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

• Male or non-pregnant female ≥18 to ≤80 years of age.
• Patient or his/her legally acceptable representative (LAR) willing to provide informed consent and comply with the required study procedures and visits.
• Patient agrees not to participate in any other investigational or invasive clinical study for a period of 2 years from the date of index procedure.
• Female patient of childbearing potential who does not plan pregnancy for up to 2 years from the date of index procedure.
• For a female patient of childbearing potential a pregnancy test must be performed with negative results at screening visit.
• Clinically all patients must be in Rutherford category 2 to 5.
• One identifiable single solitary or a series of multiple adjacent lesions in the blocked or narrowed arteries below the knee due toPeripheral Artery Disease (PAD) defined as ≥70% diameter stenosis with length in the range of ≥20 mm to ≤150 mm.
• If the index lesion is re-stenotic, the prior PTA must have been >30 days prior to treatment in the current study 9.
• Patients planned for PK analysis must agree to undergo PK follow-ups as per protocol.

Exclusion Criteria

• Patient with known hypersensitivity to contrast media or any study-required medication (antiplatelets, anticoagulants, thrombolytics, etc).
• Patient with known allergies or sensitivity to paclitaxel.
• Patient having gastrointestinal bleeding or coagulopathy.
• Patient having target lesion that the investigator is unable to cross by a guide wire.
• Patient judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper of the delivery system.
• Patient is probable case of stenting for the target lesion during the screening as per adjudication of investigator.
• Patient with severe renal insufficiency (serum creatinine >2.0 mg/dL).
• Untreated ipsilateral iliac artery.
• Acute aneurysm in target the target vessel.
• Patient participating in another device or drug study at the time of consenting process.
• Major surgical procedures (viz.
• major invasive procedures or endovascular interventions for peripheral artery disease etc.
• or surgeries that might impact safety of participating patients as per discretion of investigator) within 30 days prior to this study or planned within 2 years after entry into this study.
• Patient with life expectancy less than 2 years.
• Adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon etc) within 30 days prior to this study or planned within 30 days of entry into this study.
• Patient who required bailout stenting.
• Diagnosed with cancer or malignancy 16.
• Any medical condition, which in investigator’s opinion, may interfere with patient’s participation in the study.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse event [Time Frame: 6 months]	6 Months
- Major adverse event is defined as all-cause death, target limb amputation and clinically driven target lesion revascularization (CD-TLR)	6 Months

Secondary Outcome Measures

Name	Time	Method
Primary Patency	At post-procedure and after 6 months
Late Lumen Loss	At post-procedure and after 6 months
All cause of death	At Post-procedure, 1 month, 6 months , 12 months and 24 months
Clinically driven TLR (CD-TLR)	At Post-procedure, 1 month, 6 months , 12 months and 24 months
Target limb amputation	At Post-procedure, 1 month, 6 months , 12 months and 24 months
Change of Ankle-Brachial index (ABI)	At Baseline, Post-procedure, 1 month, 6 months , 12 months and 24 months
Walking Impairment Questionnaire (WIQ)	At 1 month, 6 months, 12 months and 24 months
Change in Rutherford Classification	At Baseline, Post-procedure, 1 month, 6 months, 12 months and 24 months
Device Success	During index procedure
Procedural Success	At Post-procedure
User Rating on Technical Properties	At index procedure

Trial Locations

Locations (1)

Apex Hospitals Pvt. Ltd; 🇮🇳 Jaipur, RAJASTHAN, India

Apex Hospitals Pvt. Ltd

🇮🇳Jaipur, RAJASTHAN, India

Dr Adarsh Kabra

Principal investigator

8290912888

aadarsh61@yahoo.com